Systems and methods for applying excimer laser energy with transverse placement in the eye

ABSTRACT

An illustrative method of delivering laser energy to a surface of a trabecular meshwork of an eye includes inserting a probe into the eye and delivering, at multiple locations along the trabecular meshwork, shots of the laser energy via the probe to create a plurality of perforations in the trabecular meshwork. The plurality of perforations form a line or curve that is transverse to a Schlemm&#39;s canal in the eye.

BACKGROUND

Glaucoma is a group of eye conditions which result in damage to theoptic nerve and lead to vision loss. While glaucoma can occur at anyage, it is more common in older adults and is one of the leading causesof blindness for people over the age of 60. Glaucoma may be caused byhigher than normal intraocular pressure within an eye, where elevatedintraocular pressure can lead to atrophy of the optic nerve, subsequentvisual field disturbances, and eventual blindness if left untreated.

SUMMARY

An illustrative method of treating a patient having an eye conditionincludes determining, during a pre-operative analysis of the patient,that the patient has a risk of developing glaucoma. The method furtherincludes treating the patient with an excimer laser to prophylacticallytreat glaucoma based on the pre-operative analysis determination thatthe patient has the risk of developing glaucoma.

In various embodiments, during the pre-operative analysis the patient isdiagnosed as having cataracts and has the risk of developing glaucoma.

In various embodiments, the applying of the excimer laser energy toprophylactically treat glaucoma occurs without the patient having beendiagnosed with glaucoma.

In various embodiments, the applying of the excimer laser energy toprophylactically treat glaucoma occurs prior to elevated intraocularpressure (TOP) being identified in the eye of the patient.

In various embodiments, the applying of the excimer laser energy toprophylactically treat glaucoma occurs without the patient actuallyhaving glaucoma.

In various embodiments, the risk is a congenital risk.

In various embodiments, the congenital risk is associated with a familyhistory, a race, a gender, or a combination thereof of the patient.

In various embodiments, the risk is a presence of a comorbidity.

In various embodiments, the presence of the comorbidity includes ocularhypertension, obesity, diabetes, closed-angled glaucoma, tobacco use,alcohol use, or a combination thereof.

In various embodiments, the risk is an age-related risk.

In various embodiments, the age-related risk includes being at or aboveage 40, at or above age 45, at or above age 50, at or above age 55, ator above age 60, at or above age 65, at or above age 70, at or above age75, or at or above age 80.

In various embodiments, the method includes determining, during thepre-operative analysis of the patient, that the patient has cataractsand applying phacoemulsification ultrasound to the patient diagnosed ashaving the cataracts.

In various embodiments, the phacoemulsification ultrasound and thetreating the patient with the excimer laser to prophylactically treatthe glaucoma is performed in a same surgical procedure on the patient.

In various embodiments, the phacoemulsification ultrasound and thetreating the patient with the excimer laser to prophylactically treatthe glaucoma are applied through a same incision in an eye of thepatient

In various embodiments, the method includes administering anesthesia tothe patient before applying the phacoemulsification ultrasound and theexcimer laser.

In various embodiments, treating the patient with the excimer laserincludes applying shots of pulsed energy from the excimer laser.

An illustrative method of treating a patient having an eye conditionincludes determining, during a pre-operative analysis of the patient,that the patient has a risk of developing glaucoma. The method furtherincludes applying, through an incision in an eye of the patient,phacoemulsification ultrasound to the patient, the patient having beendiagnosed as having cataracts in the eye. The method further includesapplying, through the incision in the eye, an excimer laser energy toprophylactically treat glaucoma based on the pre-operative analysisdetermination that the patient has the risk of developing glaucoma.

In various embodiments, the risk is a congenital risk associated with afamily history, a race, a gender, or a combination thereof of thepatient.

In various embodiments, the risk is an age-related risk or a presence ofa comorbidity.

An illustrative apparatus for delivering laser energy to a surface of atrabecular meshwork of an eye includes an excimer laser source and aprobe configured to connect to the excimer laser source. The apparatusfurther includes a delivery tip connected to the probe. The probe isconfigured to insert into the eye of a subject that does not haveglaucoma. The subject has been determined to be at risk of developingglaucoma during a pre-operative analysis of the subject. The probe isfurther configured to deliver shots from the excimer laser source tocreate perforations in the trabecular meshwork.

An illustrative method of treating a patient having an eye conditionincludes determining that the patient has a closed-angle or narrow-angleglaucoma. The method further includes treating the closed-angle ornarrow-angle glaucoma during a surgical procedure performed on thepatient. The method further includes, during the surgical procedure,treating the patient with an excimer laser to create a plurality ofperforations in the trabecular meshwork by applying a plurality of shotsto the trabecular meshwork from the excimer laser.

In various embodiments, the treating the closed-angle or narrow-angleglaucoma includes applying phacoemulsification ultrasound to thepatient.

In various embodiments, the phacoemulsification ultrasound includesbreaking up a lens of the eye.

In various embodiments, the method includes, after breaking up the lens,removing the lens from the eye of the patient.

In various embodiments, the method includes, after removing the lens,replacing the lens of the eye with an artificial lens.

In various embodiments, the artificial lens is thinner than the lens ofthe eye that is removed from the eye.

In various embodiments, the artificial lens provides a path for fluiddrainage between the artificial lens and an iris of the eye.

In various embodiments, the closed-angle or narrow-angle glaucoma causesat least partial blockage of fluid flow from an anterior chamber of theeye located between a cornea of the eye and a lens of the eye throughthe trabecular meshwork due to bulging of an iris of the eye.

In various embodiments, the treating of the closed-angle or narrow-angleglaucoma causes the bulging of the iris to decrease.

In various embodiments, the treating of the patient with the excimerlaser occurs after the bulging of the iris decreases.

In various embodiments, the treating of the patient with the excimerlaser includes inserting an excimer laser probe into an incision of theeye of the patient.

In various embodiments, the treating the closed-angle or narrow-angleglaucoma includes inserting a phacoemulsification ultrasound probe intothe incision of the eye of the patient.

In various embodiments, the incision has a length of about one eighth ofan inch or smaller.

In various embodiments, the plurality of shots includes at least tenshots.

In various embodiments, the method further includes administeringanesthesia to the patient before the treating of the closed-angle ornarrow-angle glaucoma and before the treating of the patient with theexcimer laser.

In various embodiments, the excimer laser includes a xenon chloridelaser source.

An illustrative method of treating a patient having an eye conditionincludes determining that the patient has a closed-angle or narrow-angleglaucoma. The method further includes applying a phacoemulsificationultrasound to the patient to treat the closed-angle or narrow-angleglaucoma during a surgical procedure performed on the patient. Thephacoemulsification ultrasound is applied via a phacoemulsificationprobe inserted through an incision in an eye of the patient. The methodfurther includes, during the surgical procedure, treating the patientwith an excimer laser to create a plurality of perforations in thetrabecular meshwork by applying a plurality of shots to the trabecularmeshwork from the excimer laser. The plurality of shots is applied viaan excimer laser probe inserted through the incision.

In various embodiments, the phacoemulsification ultrasound includesbreaking up a lens of the eye.

In various embodiments, the treating the patient with the excimer laseroccurs after applying the phacoemulsification ultrasound.

An illustrative apparatus for delivering laser energy to a surface of atrabecular meshwork of an eye includes an excimer laser source and aprobe configured to connect to the excimer laser source. The apparatusfurther includes a delivery tip connected to the probe. The probe isconfigured to insert into the eye of a subject having a closed-angle ornarrow-angle glaucoma. The probe is further configured to insert intothe eye after a treatment of the closed-angle or narrow-angle glaucomais performed on the subject. The probe is further configured to delivershots from the excimer laser source to create perforations in thetrabecular meshwork.

An illustrative apparatus for treating an eye includes a housing, anexcimer laser source within the housing, an ultrasound generator withinthe housing, an irrigation source within the housing, and an aspirationsource within the housing.

In various embodiments, the housing is a single housing.

In various embodiments, the apparatus further includes wheels attachedto the housing such that the apparatus is movable.

In various embodiments, the apparatus further includes two foot pedalsor the housing includes two receptacles each configured to receive aconnector for a foot pedal.

In various embodiments, the excimer laser source is controllable using afirst foot pedal of the two foot pedals.

In various embodiments, at least one of the ultrasound generator, theirrigation source, or the aspiration source is controllable using asecond foot pedal of the two foot pedals.

In various embodiments, the apparatus further includes a single powercord connected to the housing and connectable to a wall outlet.

In various embodiments, each of the excimer laser source, the ultrasoundgenerator, the irrigation source, and the aspiration source are poweredvia the single power cord.

In various embodiments, the apparatus further includes a port forconnecting an excimer laser probe to the housing.

In various embodiments, the port is a first port, and wherein theapparatus further comprises a second port for connecting aphacoemulsification probe to the housing.

In various embodiments, the ultrasound generator, the irrigation source,and the aspiration source are together configured for use with thephacoemulsification probe to perform a phacoemulsification ultrasound onan eye of a subject.

In various embodiments, the excimer laser source is configured for usewith the excimer laser probe to perform an excimer laser trabeculostomy(ELT) procedure on the eye of the subject.

In various embodiments, the apparatus further includes a display on thehousing.

In various embodiments, the apparatus further includes an energy monitorport on the housing.

In various embodiments, the energy monitor port is configured to receivea first distal end of a phacoemulsification probe and is configured toreceive a second distal end of an excimer laser probe.

In various embodiments, the apparatus further includes a sensor in theenergy monitor port configured to receive light emitted by thephacoemulsification probe and the excimer laser probe to calibrate powerbeing emitted by the phacoemulsification probe and the excimer laserprobe, respectively.

An illustrative apparatus for treating an eye includes a housing and anexcimer laser source within the housing configured to perform an excimerlaser trabeculostomy (ELT). The apparatus further includes componentsconfigured to perform a phacoemulsification ultrasound including, anultrasound generator within the housing, an irrigation source within thehousing, and an aspiration source within the housing.

In various embodiments, the apparatus further includes a single powercord connected to the housing and connectable to a wall outlet.

In various embodiments, the apparatus further includes a first port forconnecting an excimer laser probe to the housing and a second port forconnecting a phacoemulsification probe to the housing.

An illustrative method for treating an eye includes performing anexcimer laser trabeculostomy (ELT) with an excimer laser source housedin a single housing. The method further includes performing aphacoemulsification ultrasound with components housed in the singlehousing. The components include an ultrasound generator within thehousing, an irrigation source within the housing, and an aspirationsource within the housing.

An illustrative method of delivering laser energy to a surface of atrabecular meshwork of an eye includes inserting a probe into the eyeand delivering, at multiple locations along the trabecular meshwork,shots of the laser energy via the probe to create a plurality ofperforations in the trabecular meshwork. The plurality of perforationsform a line or curve that is transverse to a Schlemm's canal in the eye.

In various embodiments, the laser energy is delivered from an excimerlaser source.

In various embodiments, the plurality of perforations are created in thetrabecular meshwork in order to treat glaucoma.

In various embodiments, at least one of the plurality of perforations inthe trabecular meshwork is not aligned with the Schlemm's canal.

In various embodiments, at least one of the plurality of perforations inthe trabecular meshwork does not create a fluid connection between theSchlemm's canal and an anterior chamber of the eye located between acornea of the eye and a lens of the eye.

In various embodiments, at least one of the plurality of perforations inthe trabecular meshwork is aligned with the Schlemm's canal.

In various embodiments, at least one of the plurality of perforations inthe trabecular meshwork creates a fluid connection between the Schlemm'scanal and an anterior chamber of the eye located between a cornea of theeye and a lens of the eye.

In various embodiments, a light source comprising a Gonio lens,endoscope, or other illumination source aids in adjusting placement ofthe probe.

In various embodiments, the plurality of shots comprises 10 shots pereye.

In various embodiments, the plurality of shots comprises greater than 10shots per eye.

In various embodiments, each of the plurality of perforations has adiameter of approximately 200 μm.

In various embodiments, the probe is inserted into an incision in theeye.

In various embodiments, the method further includes analyzingeffectiveness of the shots by visualizing drainage of aqueous humor andbloody reflux.

In various embodiments, the probe is an optical fiber probe.

In various embodiments, the laser energy is delivered from an excimerlaser source comprising a xenon chloride laser.

In various embodiments, the method further includes physicallycontacting the trabecular meshwork with the probe while delivering theplurality of shots. The plurality of perforations are created while theprobe is physically contacting the trabecular meshwork.

An illustrative method of delivering laser energy to a surface of atrabecular meshwork of an eye includes inserting a probe into an eye ofa subject having glaucoma and adjusting placement of the probe to afirst position proximate to the trabecular meshwork in the eye. Themethod further includes delivering a first shot from a laser source tocreate a first perforation in the trabecular meshwork. The methodfurther includes adjusting placement of the probe to a second positionproximate to the trabecular meshwork. The method further includesdelivering a second shot from the laser source to create a secondperforation in the trabecular meshwork. The first perforation and thesecond perforation form a line that runs transverse to a Schlemm's canalof the eye.

In various embodiments, the method further includes adjusting placementof the probe to subsequent positions proximate to the trabecularmeshwork and delivering subsequent shots from the laser source to createsubsequent perforations in the trabecular meshwork. The firstperforation, the second perforation, and the subsequent perforationsform a line or curve that runs transverse to the Schlemm's canal of theeye.

In various embodiments, the laser source includes an excimer lasersource.

An illustrative apparatus for delivering laser energy to a surface of atrabecular meshwork of an eye to treat glaucoma includes an excimerlaser source and a probe configured to connect to the excimer lasersource. The apparatus further includes a delivery tip connected to theprobe. The probe is configured to insert into the eye of a subjecthaving the glaucoma, move to a first position proximate to thetrabecular meshwork in the eye, deliver a first shot from the excimerlaser source to create a first perforation in the trabecular meshwork,move to a second position proximate to the trabecular meshwork, anddeliver a second shot from the excimer laser source to create a secondperforation in the trabecular meshwork. The first perforation and thesecond perforation form a line that runs transverse to a Schlemm's canalof the eye.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is schematic sectional view of an eye illustrating the interioranatomical structure.

FIG. 2 is a perspective fragmentary view of the anatomy within theanterior chamber of an eye depicting the comeoscleral angle.

FIG. 3 diagrams an excimer laser system of the present disclosure.

FIG. 4 shows an embodiment an excimer laser system.

FIG. 5 shows an embodiment of a probe for use with the excimer lasersystem.

FIG. 6 shows an embodiment of a probe for use with the excimer lasersystem.

FIG. 7 is a schematic sectional view of an embodiment in an eye.

FIG. 8 shows the schematic section view of an eye with a light sourceaid.

FIG. 9 is an enlarged schematic sectional view of an embodiment.

FIG. 10 is a flowchart of an embodiment of methods for applying ELTafter a pre-operative analysis.

FIG. 11 is a flowchart of an embodiment of performing a pre-operativeanalysis and ELT treatment of a patient.

FIGS. 12A and 12B demonstrate a normal eye and an eye with closed angleglaucoma.

FIG. 13 shows an embodiment of systems for phaco and ELT treatment.

FIG. 14 shows an embodiment of systems for combined phaco and ELTtreatment.

FIG. 15 shows an embodiment of a phaco system.

FIG. 16 shows an embodiment of a phaco probe.

FIG. 17 shows an embodiment of a foot pedal.

FIG. 18 shows an embodiment of a foot pedal.

FIG. 19 shows an embodiment of a foot pedal.

FIG. 20 shows an embodiment of a foot pedal.

FIG. 21A shows an embodiment of combined ELT and phaco system.

FIG. 21B shows an embodiment of combined ELT and phaco system.

FIG. 22 shows a cross-sectional view of the probe taken along line A-Aof FIG. 6 .

FIG. 23 shows a cross-sectional view of the probe taken along line B-Bof FIG. 6 .

FIG. 24 shows an enlarged view of the delivery tip of a probe emittingboth visible light for illuminating a field of view and laser energy forphotoablation of a target tissue.

FIG. 25 shows an alternative cross-sectional view of the probe takenalong line A-A of FIG. 6 .

FIG. 26 shows an alternative cross-sectional view of the probe takenalong line B-B of FIG. 6 .

FIG. 27 diagrams an excimer laser system of the present disclosure.

FIG. 28 diagrams the excimer laser system of the present disclosure andauthentication of a laser probe to be used with the excimer lasersystem.

FIG. 29 shows an embodiment of a probe for use with the excimer lasersystem.

FIG. 30 shows a cross-sectional view of the probe taken along line A-Aof FIG. 4 .

FIG. 31 shows a cross-sectional view of the probe taken along line B-Bof FIG. 4 .

FIG. 32 shows an embodiment a laser probe attached to an excimer laserunit.

FIG. 33 shows an enlarged view of a connection between the laser probeand the excimer unit and initial RFID reading to determine authenticityof the laser probe.

FIG. 34 is a flowchart of an embodiment for authenticating a probe foruse with an excimer laser unit.

FIG. 35 is a flowchart of an embodiment for preventing use of anunauthenticated probe. with an excimer laser unit.

FIG. 36 diagrams an excimer laser system of the present disclosure.

FIG. 37 diagrams the excimer laser system of the present disclosure andhow the system may be used to calibrate laser output to compensate forincreased variation in optical fibers of laser probes.

FIG. 38 diagrams a process of calibrating laser output, includingadjustment of laser energy output from the laser source to a laser probeto account for variation in the fiber optic core of the laser probe.

FIG. 39 shows an embodiment of a probe for use with the excimer lasersystem.

FIG. 40 is a flowchart of an embodiment of methods of applying ELT aftera previous, ineffective treatment.

FIG. 41 shows an embodiment of an ELT system with an interactive userinterface.

FIG. 42 is a flowchart of an embodiment of methods using placement of aprobe to create perforations that form a line transverse to Schlemm'scanal.

FIG. 43 is a perspective fragmentary view of the anatomy within theanterior chamber of an eye depicting the comeoscleral angle, with shotsapplied to the trabecular meshwork in a transverse line.

FIG. 44 diagrams an excimer laser system of the present disclosure.

FIG. 45 shows an embodiment an excimer laser unit.

FIG. 46 shows a cross-sectional view of the probe taken along line A-Aof FIG. 6 .

FIG. 47 shows a cross-sectional view of the probe taken along line B-Bof FIG. 6 .

FIG. 48 shows an enlarged view of a distal portion of a probe.

FIGS. 49A and 49B show enlarged views of delivery tips of a probe havingdifferent bevel angles.

FIGS. 50 and 51 show enlarged views of a distal portion of a probeflexing in different directions.

FIG. 52 is a flowchart of an embodiment of methods of applying ELT withprogrammable customizations.

FIG. 53 shows a stylized embodiment of an interactive user interface.

DETAILED DESCRIPTION

A major risk factor in glaucoma is ocular hypertension, in whichintraocular pressure is higher than normal. An elevated intraocularpressure can lead to atrophy of the optic nerve, subsequent visual fielddisturbances, and eventual blindness if left untreated.

Intraocular pressure is a function of the production of aqueous humorfluid by the ciliary processes of the eye and its drainage through atissue called the trabecular meshwork. The trabecular meshwork is anarea of tissue in the eye located around the base of the cornea and isresponsible for draining the aqueous humor into a lymphatic-like vesselin the eye called Schlemm's canal, which subsequently delivers thedrained aqueous humor into the bloodstream. Proper flow and drainage ofthe aqueous humor through the trabecular meshwork keeps the pressureinside the eye normally balanced. In open-angle glaucoma, the mostcommon type of glaucoma, degeneration or obstruction of the trabecularmeshwork can result in slowing or completely preventing the drainage ofaqueous humor, causing a buildup of fluid, which increases theintraocular pressure. Under the strain of this pressure, the optic nervefibers become damaged and may eventually die, resulting in permanentvision loss.

If treated early, it is possible to slow or stop the progression ofglaucoma. Depending on the type of glaucoma, treatment options mayinclude eye drops, oral medications, surgery, laser treatment, or acombination of any of these. For example, treatment of open-angleglaucoma may include surgical treatments, such as filtering surgery, inwhich an opening is created in the sclera of the eye and a portion ofthe trabecular meshwork is removed, and surgical implantation of stentsor implants (i.e., drainage tubes), in which a small tube shunt ispositioned within the eye to assist in fluid drainage. However, suchtreatments are highly invasive and may present many complications,including leaks, infections, hypotony (e.g., low eye pressure), andrequire post-operative, long-term monitoring to avoid latecomplications.

More recently, minimally invasive laser treatments have been used totreat glaucoma. In such treatments, the surgeon uses a laser tothermally modify and/or to puncture completely through variousstructures, including the trabecular meshwork and/or Schlemm's canal.For example, a laser trabeculostomy is a procedure in which a surgeonguides a working end of a laser fiber through a corneal incision of theeye and towards the trabecular meshwork and applies laser energy todestroy portions of the meshwork to create channels in the meshworkwhich allow aqueous humor to flow more freely into the Schlemm's canal.

In order to fully appreciate the various embodiments described herein, abrief overview of the anatomy of the eye is provided. FIG. 1 isschematic sectional view of an eye illustrating the interior anatomicalstructure. As shown, the outer layer of the eye includes a sclera 17that serves as a supporting framework for the eye. The front of thesclera includes a cornea 15, a transparent tissue that enables light toenter the eye. An anterior chamber 7 is located between the cornea 15and a crystalline lens 4. The anterior chamber 7 contains a constantlyflowing clear fluid called aqueous humor 1. The crystalline lens 4 isconnected to the eye by fiber zonules, which are connected to theciliary body 3. In the anterior chamber 7, an iris 19 encircles theouter perimeter of the lens 4 and includes a pupil 5 at its center. Thepupil 5 controls the amount of light passing through the lens 4. Aposterior chamber 2 is located between the crystalline lens 4 and theretina 8.

FIG. 2 is a perspective fragmentary view of the anatomy within theanterior chamber of an eye depicting the comeoscleral angle. As shown,the anatomy of the eye further includes a trabecular meshwork 9, whichis a narrow band of spongy tissue that encircles the iris 19 within theeye. The trabecular meshwork has a variable shape and is microscopic insize. It is of a triangular cross-section and of varying thickness inthe range of 100-200 microns. It is made up of different fibrous layershaving micron-sized pores forming fluid pathways for the egress ofaqueous humor. The trabecular meshwork 9 has been measured to about athickness of about 100 microns at its anterior edge, Schwalbe's line 18,which is at the approximate juncture of the cornea 15 and sclera 17.

The trabecular meshwork widens to about 200 microns at its base where itand iris 19 attach to the scleral spur. The passageways through thepores in trabecular meshwork 9 lead through very thin, porous tissuecalled the juxtacanalicular trabecular meshwork 13 that in turn abutsthe interior side of a structure called Schlemm's canal 11. Schlemm'scanal 11 is filled with a mixture of aqueous humor and blood componentsand branches off into collector channels 12 which drain the aqueoushumor into the venous system. Because aqueous humor is constantlyproduced by the eye, any obstruction in the trabecular meshwork, thejuxtacanalicular trabecular meshwork or in Schlemm's canal prevents theaqueous humor from readily escaping from the anterior eye chamber whichresults in an elevation of intraocular pressure within the eye.

The eye has a drainage system for the draining aqueous humor 1 locatedin the corneoscleral angle. In general, the ciliary body 3 produces theaqueous humor 1. This aqueous humor flows from the posterior chamber 2through the pupil 5 into the anterior chamber 7 to the trabecularmeshwork 9 and into Schlemm's canal 11 to collector channels 12 toaqueous veins. The obstruction of the aqueous humor outflow which occursin most open angle glaucoma (i.e., glaucoma characterized bygonioscopically readily visible trabecular meshwork) typically islocalized to the region of the juxtacanalicular trabecular meshwork 13,which is located between the trabecular meshwork 9 and Schlemm's canal11, more specifically, the inner wall of Schlemm's canal. It isdesirable to correct this outflow obstruction by enhancing the eye'sability to use the inherent drainage system.

When an obstruction develops, for example, at the juxtacanaliculartrabecular meshwork 13, intraocular pressure gradually increases overtime, thereby leading to damage and atrophy of the optic nerve,subsequent visual field disturbances, and eventual blindness if leftuntreated. The laser probe of the present embodiments is well suited foruse in treating glaucoma. In particular, as will be described in greaterdetail herein, the laser probe is configured to be coupled to a lasersource and transmit laser energy from the laser source to the trabecularmeshwork 13, resulting in photoablation of tissue (including at leastthe trabecular meshwork 13 and, in some instances, the Schlemm's canal11) for the creation of channels in the meshwork (and potentiallySchlemm's canal 11, thereby improving fluid drainage into the Schlemm'scanal 11 and reducing intraocular pressure in the eye.

FIG. 3 diagrams an excimer laser system 100 of the present disclosure.The system 100 includes a probe member 102, which includes a lasertransmitting member 103 and an illumination member 104, a controller106, a laser source 108, and a light source 110. As will be described ingreater detail herein, many of the components of the laser system 100may be contained in a housing, such as a moveable platform, to beprovided in a setting in which the procedure is to be performed (e.g.,operating room, procedure room, outpatient office setting, etc.) and theprobe member 102 may connect to the housing for use during treatment.Upon coupling the probe member 102 to the housing, the lasertransmitting member 103 and illumination member 104 are each coupled tothe respective laser source 108 and light source 110. The controller 106provides an operator (i.e., surgeon or other medical professional) withcontrol over the output of laser signals (from the laser source 108 tothe laser transmitting member 103) and, in turn, control over thetransmission of laser energy from the laser transmitting member 103 ofthe probe 102. The controller 106 further provides the operator withcontrol over the output of light signals (from the light source 110 tothe illumination member 104) and, in turn, control over the emission oflight from the illumination member 104.

The controller 106 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 106 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the laser system 100 as described herein, includingcontroller laser and/or illumination output.

The laser source 108 may include an excimer laser 112 and a gascartridge 114 for providing the appropriate gas combination to the laser112. The excimer laser 112 is a form of ultraviolet laser that generallyoperates in the UV spectral region and generates nanosecond pulses. Theexcimer gain medium (i.e., the medium contained within the gas cartridge114) is generally a gas mixture containing a noble gas (e.g., argon,krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine).Under the appropriate conditions of electrical stimulation and highpressure, a pseudo-molecule called an excimer (or in the case of noblegas halides, exciplex) is created, which can only exist in an energizedstate and can give rise to laser light in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 112of the present system 100 is an XeCl excimer laser and emits awavelength of 308 nm.

The light source 110 provides a light signal to the illumination member104 within the visible light spectrum. Accordingly, the illuminationsource 110 may include, but is not limited to, an incandescent lightsource, a fluorescent light source, a halogen light source, ahigh-intensity discharge light source, a metal halide light source, anda light emitting diode (LED) light source.

FIG. 4 shows an embodiment an excimer laser system 100 provided in aninstrument 400. As previously described, one or more components of thesystem 100 can be contained within the instrument 400. In the presentembodiment, the controller 106, the laser source 108 (including theexcimer laser 112 and gas cartridge 114), and the light source 110 arecontained within a housing 402. The housing 402 has wheels 404 and isportable. The instrument 400 further includes a push-pull handle 405which assists with portability of the instrument 400. The instrument 400further includes a connection port 406 for receiving a connecting end ofthe probe member 102 to establish a connection between the lasertransmitting member 103 and illumination member 104 and the respectivelaser source 108 and light source 110. The instrument 400 furtherincludes various inputs for the operator, such as a fiber probe capholder 408, an emergency stop button 410, and a power switch 412. Theinstrument 400 further includes a foot pedal 414 extending from thehousing 402 and is operable to provide control over the delivery ofshots from the excimer laser 412 to the laser transmitting member 103 ofthe probe 102. The instrument 400 further includes a display 416, whichmay be in the form of an interactive user interface. In some examples,the interactive user interface 410 displays patient information, machinesettings, and procedure information.

FIG. 5 shows an embodiment of a probe 500 for use with the excimer lasersystem 100, illustrating the probe 500 having a capped, distal deliverytip 506. FIG. 6 shows an embodiment of the probe 500 with the cap 514removed, exposing the delivery tip 506 of the probe 500. The probe 500is a single use, disposable unit. The probe 500 generally includes alaser transmitting member and an illumination member as previouslydescribed herein, wherein each are coupled to their respective sources(i.e., laser source 108 and light source 110) by way of a connector 502(elongated cord) extending from the body of the probe 500 and having aconnection assembly 504 configured to be received within the connectionport 406 of the instrument 400. The probe 500 further includes adelivery tip 506 from which laser energy (from the laser transmittingmember) and visible light (from the illumination member) may be emitted.The probe 500 includes a handheld body 508, which may include a fingergrip 510 with ridges or depressions 512. The body 508 of the handheldprobe 500 may be metal or plastic.

FIG. 7 is schematic sectional view of an eye 2100 illustrating theinterior anatomical structure. FIG. 8 shows the schematic section viewof an eye 2100 with a light source 2190, such as a Gonio lens,endoscope, or other light source. FIG. 9 is an enlarged schematicsectional view of the eye. The outer layer, or sclera, 2130 serves as asupporting framework for the eye, and the front of the outer layer 2130includes a cornea 2125, a transparent tissue that enables light to enterthe eye. An anterior chamber 2135 is located between the cornea 2125 anda crystalline lens 2110, and a posterior chamber is located behind thelens 2110. The anterior chamber 2135 contains a constantly flowing clearfluid called aqueous humor. In the anterior chamber 2135, an iris 2120encircles the outer perimeter of the lens 2110 and includes a pupil atits center, which controls the amount of light passing through the lens2110.

The eye further includes a trabecular meshwork 2140, which is a narrowband of spongy tissue that encircles the iris 2120 within the eye. Thetrabecular meshwork has a variable shape and is microscopic in size. Itis of a triangular cross-section and of varying thickness in the rangeof 100-200 microns. It is made up of different fibrous layers havingmicron-sized pores forming fluid pathways for the egress of aqueoushumor. The trabecular meshwork 2140 has been measured to about athickness of about 100 microns at its anterior edge, known as Schwalbe'sline, which is at the approximate juncture of the cornea and sclera.

The trabecular meshwork widens to about 200 microns at its base where itand iris 2120 attach to the scleral spur. The passageways through thepores in trabecular meshwork 2140 lead through very thin, porous tissuecalled the juxtacanalicular trabecular meshwork that abuts the interiorside of a structure called Schlemm's canal 2150. Schlemm's canal 2150 isfilled with a mixture of aqueous humor and blood components and branchesoff into collector channels which drain the aqueous humor into thevenous system. Because aqueous humor is constantly produced by the eye,any obstruction in the trabecular meshwork, the juxtacanaliculartrabecular meshwork or in Schlemm's canal prevents the aqueous humorfrom readily escaping from the anterior eye chamber which results in anelevation of intraocular pressure within the eye.

The eye has a drainage system for the draining aqueous humor. Theaqueous humor flows from a posterior chamber behind the lens 2110through the pupil into the anterior chamber 2135 to the trabecularmeshwork 2140 and into Schlemm's canal 2150 to collector channels andthen to aqueous veins. The obstruction of the aqueous humor outflowwhich occurs in most open angle glaucoma (i.e., glaucoma characterizedby gonioscopically readily visible trabecular meshwork) typically islocalized to the region of the juxtacanalicular trabecular meshworklocated between the trabecular meshwork 2140 and Schlemm's canal 2150,more specifically, the inner wall of Schlemm's canal. When anobstruction develops, such as at the juxtacanalicular trabecularmeshwork or at Schlemm's canal, intraocular pressure gradually increasesover time, leading to damage and atrophy of the optic nerve, subsequentvisual field disturbances, and eventual blindness if left untreated.

A laser probe according to various embodiments is used to treatglaucoma. The delivery tip of the laser probe 2160 is guided through asmall incision, typically about ⅛ inch or smaller, in the cornea 2125 ofthe eye and across the anterior chamber 2135 to a position proximate tothe Schlemm's canal 2150. The probe is guided very flat through theanterior chamber to avoid perforating the cornea in the visual field.The laser probe is coupled to a laser source and transmits laser energyfrom the laser source to the trabecular meshwork 2140 and Schlemm'scanal 2150, resulting in photoablation of tissue including at least thetrabecular meshwork 2140 and, in some instances, the Schlemm's canal2150. The photoablation from the laser energy creates perforations inthe meshwork and Schlemm's canal, thereby improving fluid drainage intothe Schlemm's canal 2150 and reducing intraocular pressure in the eye.

FIG. 9 shows the arrangement of the delivery tip 2160 at a positionproximate 2170 to the Schlemm's canal 2150. Arrangement of the laser ata proximate position to the Schlemm's canal allows the laser path totravel crosswise through the trabecular meshwork to the Schlemm's canal.By positioning the laser proximate to the Schlemm's canal, the laser isable to provide photoablation to a greater amount of surface area of thetrabecular meshwork in comparison to a laser arranged at positionsperpendicular or parallel to the Schlemm's canal. Moreover, if thedelivery tip of the laser was positioned parallel to the Schlemm'scanal, the laser would not provide photoablation to any surface area ofthe trabecular meshwork or Schlemm's canal.

ELT Treatment Based on Risk Factors and Combination Treatments UsingPhaco and ELT

Many people suffer vision loss due to cataracts or glaucoma. Cataractsare a common condition that occurs when light is blocked from enteringthe eye due to cloudiness or opacity in the lens of the eye. Patientssuffering from glaucoma experience vision loss caused by damage to theoptic nerve due to buildup of fluid in the anterior chamber of the eye.

The risk of developing cataracts, glaucoma, or both, increases with age;and many people over the age of 60 suffer from both vision-alteringconditions. Moreover, patients diagnosed with cataracts at a young agehave a higher risk of developing glaucoma later in life. Patientsdiagnosed with either condition undergo treatment ranging frommedication to surgery.

The various embodiments provide systems and methods for prophylactictreatment of glaucoma in patients being treated for cataracts. Accordingto various embodiments, a patient who presents for cataracts removal isevaluated and, if appropriate, prophylactically treated to preventglaucoma. The various embodiments take advantage of the insight thatcertain patients with cataracts, especially at a younger age, are likelyto develop glaucoma later in life, may be in the early stages ofdeveloping glaucoma, or may be at high risk for developing glaucoma doto family history, racial background, underlying medical conditions, orother factors. The various embodiments include evaluating cataractspatients to determine whether an additional procedure as describe belowwould be beneficial to prevent the onset of glaucoma. Accordingly,methods of the various embodiments comprise selecting patients beingtreated for cataracts for prophylactic treatment of glaucoma. It shouldbe noted that, while an excimer laser trabeculostomy (ELT) procedure isthe preferable prophylactic glaucoma treatment in accordance with thevarious embodiments herein, other procedures known in the art may beused for prophylactic glaucoma treatment.

In various embodiments described herein an ELT procedure may beperformed prophylactically with or without performing the other types oftreatment described herein, such as the phacoemulsification treatmentsdescribed below. As such, the ELT procedure may be performed based on adiagnosis of a patient that they are at high risk for developingglaucoma or have a congenital or other risk factor for developingglaucoma as described herein.

Phacoemulsification treatment (also referred to herein as “phaco”) is acommon method for removal of cataracts. Various embodiments compriseadministering phaco and ELT during the same surgical visit, therebyminimizing the amount of surgeries for a patient having multiple eyeconditions. Because phaco and ELT are less invasive than traditionalsurgeries, the amount of recovery time for the patient is minimized. Infact, both phaco and ELT are performed through one small incision madewithin a patient's eye. In various embodiments, a laserphaco proceduremay be used in lieu of a phacoemulsification treatment. In suchembodiments, a laserphaco machine and/or a combined ELT/laserphacomachine may be used in accordance with the various embodiments herein inthe same way a phacoemulsification and/or a combinedELT/phacoemulsification machine may be used. In various embodimentshowever, regardless of what type of machine is used (standalone ELT orcombined ELT/phaco machine), an ELT procedure may alone be performed(without a cataracts treatment such as phaco), for example to treatglaucoma and/or to prophylactically treat glaucoma as described herein.

Any cataracts treatment suffices for use in various embodiments.Phacoemulsification is a preferred cataracts treatment in which a smallincision is made in the peripheral cornea and an ultrasonic probe isinserted. The incision is long enough to allow entry of the ultrasonicprobe and additional instruments used for removal of the cataract.Typically, the incision is about ⅛ inch long. The ultrasonic probebreaks the cataract into small pieces which are then removed from theeye. The ultrasonic probe typically has a titanium or steel needle thatvibrates at ultrasonic frequency to emulsify the cataract while a pumpaspirates particles through the tip of the needle. To facilitateremoval, the physician may use a chipping tool and an irrigator. A clearreplacement intraocular lens (IOL) is then inserted through theincision.

Before closing the incision, methods of the various embodiments allowfor the performance of an excimer laser trabeculostomy for prophylactictreatment of glaucoma. In various embodiments, an excimer laser may beused to create perforations in the Schlemm's canal and/or the trabecularmeshwork of the eye, thereby allowing drainage of fluid from the eye.ELT treats open-angle glaucoma at the site of occurrence by increasingthe permeability of the trabecular meshwork. During ELT, the lasercreates a direct connection between the front chamber of the eye and theSchlemm's canal by using a fiber probe in physical contact with thetrabecular meshwork. The fiber probe comprises an optical fiber suitablefor UV light that is embedded into a handheld laser applicator. In someexamples, a FIDO LASER APPLICATOR manufactured by MLase AG is used asthe fiber probe.

The ELT procedure comprises guiding a laser light to the trabecularmeshwork in the iridocorneal angle via a small corneal incision. Agoniolens may be used to achieve effective, precise positioning of anend of the fiber probe at the trabecular meshwork to create a passagewayinto Schlemm's canal. A physician uses the goniolens to intraoperativelyobserve quality criteria, including reflux hemorrhage and minor refluxbleeding.

To achieve easier drainage of the aqueous humor in order to reduce IOP,a total of about ten ELT sites or perforations, each included a diameterof approximately 200 μm, are lasered into the trabecular meshwork and/orSchlemm's canal by way of laser ablation or photoablation. Incomparison, stents and implants have smaller individual diameters thatare between about 80 μm to about 120 μm. The photoablative excimer laseroperates at a wavelength of 308 nm. In some examples, the excimer laseris an encapsulated xenon chloride (XeCl) excimer laser such as the EXTRA LASER manufactured by MLase AG. Because ELT is a non-thermalprocedure, tissue reactions in the trabecular meshwork are not shown oractivated post-operatively. The lack of heat generation in ELT allowsfor a nearly absent activation of postoperative tissue reactions andprovides long-term stability of the pressure-reducing effects. Moreover,unlike the traditional glaucoma treatment method of shunt or stentplacement, the stability of Schlemm's canal using ELT treatment remainsunchanged.

Methods of the various embodiments comprise treating a subject havingone or more eye conditions and providing ELT as preventative treatment.Phacoemulsification ultrasound is applied to a subject having one ormore eye conditions, and an excimer laser is applied to an eye of thesubject to increase blood flow to an eye of the subject. Applying anexcimer laser to the eye comprises applying shots of pulsed energy fromthe excimer laser. In some examples, about 10 shots of pulsed energy areapplied to the eye. In an example, the one or more eye conditionscomprise cataracts and glaucoma.

In some cases, applying an excimer laser prophylactically treatsglaucoma. Methods of the various embodiments further compriseadministering anesthesia to the subject before applying thephacoemulsification ultrasound and the excimer laser. In someembodiments, methods of the various embodiments further comprisepost-operative analysis. For example, post-operative analysis comprisesobserving fluid flowing from Schlemm's canal in the eye.

Systems of the various embodiments are used for treatment of a subjecthaving one or more eye conditions. Systems of the various embodimentsare used to treat cataracts and preventatively treat glaucoma during thesame surgical visit, thereby eliminating the need for multiple surgeriesto treat the two conditions. By preventatively treating glaucoma,irreversible vision loss from glaucoma may be avoided. Systems include aphacoemulsification ultrasound system comprising an ultrasound probe fortreating a cataract in an eye of a subject, and an excimer laser systemcomprising an excimer laser and a fiber probe for increasing blood flowto the eye of the subject. In some examples, increasing blood flow tothe eye prophylactically treats glaucoma in the subject.

Moreover, methods of the various embodiments provide treatment for bothconditions and can decrease the amount of, or eliminate the need for,medications to manage the eye conditions. In an example, cataractmedication is eliminated because phaco is effective in reversing visionloss due to cataracts. In an example, the IOP is lowered by the ELTprocedure, and medication to treat glaucoma is reduced or eliminatedbecause eye drops that lower IOP by decreasing the amount of fluidproduced or increasing fluid flow output are unnecessary.

In an embodiment, a physician uses systems of the various embodiments toperform phaco for the treatment of cataracts and ELT for thepreventative treatment of glaucoma. An interactive user interfacedisplays patient information, machine settings, and procedureinformation. The physician uses different instruments and probesdepending on the treatment procedure. For example, the physician uses anultrasonic handheld probe for phaco and a fiberoptic probe for ELT. Thefiber probe comprises an optical fiber having a tip. In someembodiments, the tip comprises the optical fiber jacketed in stainlesssteel. In some cases, the tip is beveled. In certain embodiments, thefiber probe is disposable.

The physician is able to keep both hands free for use with therespective probes and other instruments during the procedure by using afoot pedal as the power source for each procedure. In some embodiments,the phacoemulsification ultrasound system further comprises a foot pedalto power application of ultrasound, irrigation, and aspiration to removethe cataract from the eye of the subject. In some embodiments, theexcimer laser system further comprises a foot pedal to power the excimerlaser and deliver a shot from the excimer laser to the eye of thesubject. For example, the foot pedal is used by the physician to providepower to the fiber used for ELT, such as by providing laser shots.

Other instruments used by the physician include a goniolens, a chippingtool, and an irrigator. The user interface provides any suitableinformation. For instance, the user interface provides settings of themachine, such as number of laser shots administered with each tap of thefoot pedal. The user interface displays patient information or procedureinformation.

In some embodiments, the patient is administered an anesthetic beforesurgery. In some examples, the anesthesia is topical. In some examples,the anesthesia comprises anesthetic drops. In some instances, generalanesthesia is administered to the patient. In an example, the eye isanesthetized first with eye drops and then an injection of anesthetic isadministered around the eye to prevent pain and excessive eye movementduring surgery.

A method of treating a subject having one or more eye conditionscomprises applying phacoemulsification ultrasound to a subject havingone or more eye conditions; and applying an excimer laser to the subjectto preventatively treat glaucoma. A system for treatment of one or moreeye conditions in a subject comprises a phacoemulsification ultrasoundsystem and an excimer laser system. Methods and systems of the variousembodiments prophylactically treat glaucoma in the subject. The phacosystem comprises an ultrasound probe for treating cataracts in thesubject. The excimer laser system comprises an excimer laser and a fiberprobe that applies pulsed shots of energy from the excimer laser to theeye.

Various embodiments provide methods and systems for treatment of bothcataracts and glaucoma during one surgical procedure. Methods of thevarious embodiments treat a subject having cataracts and glaucoma withphacoemulsification (phaco) and excimer laser trabeculostomy (ELT).Phaco removes the cataract and inserts a clear replacement lens. ELTincreases the flow of aqueous humor in the eye by perforating thetrabecular meshwork with a laser. Phaco and ELT are administered duringthe same surgical visit, thereby minimizing the amount of surgeries fora patient having multiple eye conditions. Because phaco and ELT are lessinvasive than traditional surgeries, the amount of recovery time for thepatient is minimized. In fact, both phaco and ELT are performed throughone small incision that is made in the eye.

In some cases, various embodiments provide methods of treating adiagnosed eye condition and prophylactically treating a second eyecondition during the same procedure. For example, a patient may bediagnosed with cataracts and require phaco surgery. Because certain ofthose patients with cataracts have a congenital risk of developingglaucoma, methods of the various embodiments administer prophylactic ELTtreatment during the same surgical procedure as phaco treatment. The ELTprovides treatment of glaucoma by increasing and/or improving outflow ofaqueous humor to the eye. Thus, the patient diagnosed with cataractswill receive treatment for both eye conditions—cataracts andglaucoma—during the same surgical procedure.

FIG. 10 shows a flowchart of an embodiment 3100. Methods of the variousembodiments are directed to treatment of multiple eye conditions in apatient. In some examples, methods include 3110 pre-operative analysisand diagnosis of the eye conditions. In some embodiments, the diagnosedeye condition is cataracts and requires phacoemulsification surgery. Thepatient may also suffer from glaucoma. In various embodiments, excimerlaser trabeculostomy (ELT) is used to treat glaucoma. In some cases, theELT is provided as prophylactic treatment for glaucoma, as individualswith cataracts have an increased risk of developing glaucoma.

A patient having one or more eye conditions is prepared for surgery. Themethod includes 3120 administering anesthesia to the patient. Topicalanesthesia is most commonly employed, typically by the instillation of alocal anesthetic such as tetracaine or lidocaine. Alternatively,lidocaine and/or longer-acting bupivacaine anesthetic may be injectedinto the area surrounding (peribulbar block) or behind (retrobulbarblock) the eye muscle cone to more fully immobilize the extraocularmuscles and minimize pain sensation. A facial nerve block usinglidocaine and bupivacaine may occasionally be performed to reduce lidsqueezing. General anesthesia is recommended for children, traumatic eyeinjuries with cataract, for very apprehensive or uncooperative patientsand animals. Cardiovascular monitoring is preferable in local anesthesiaand is mandatory in the setting of general anesthesia. Proper sterileprecautions are taken to prepare the area for surgery, including use ofantiseptics like povidone-iodine. Sterile drapes, gowns and gloves areemployed. A plastic sheet with a receptacle helps collect the fluidsduring phacoemulsification. An eye speculum is inserted to keep theeyelids open.

A physician 3130 makes a small incision on the eye of the patient.Before the phacoemulsification or ELT procedures can be performed, asmall incision is made in the eye to allow the introduction of surgicalinstruments. Through the small incision, treatment procedures areadministered during one surgical procedure.

The procedure includes 3140 applying phacoemulsification (phaco)treatment to the patient. Phacoemulsification is a modern cataractsurgery in which the eye's internal lens is emulsified with anultrasonic handpiece and aspirated from the eye. The physician removesthe anterior face of the capsule that contains the lens inside the eye.The probe used during phaco is an ultrasonic handpiece with a titaniumor steel needle. The tip of the needle vibrates at ultrasonic frequencyand is used to sculpt and emulsify the cataract. A pump aspiratesparticles through the tip of the ultrasonic handpiece. In sometechniques, a second fine steel instrument called a “chopper” is usedfrom a side port to help with chopping the nucleus into smaller pieces.The cataract is usually broken into two or four pieces and each piece isemulsified and aspirated out with suction. The nucleus emulsificationmakes it easier to aspirate the particles. After removing all hardcentral lens nucleus with phacoemulsification, the softer outer lenscortex is removed with suction only.

An irrigation-aspiration probe or a bimanual system is used to aspirateout the remaining peripheral cortical matter, while leaving theposterior capsule intact. An intraocular lens implant (IOL), is placedinto the remaining lens capsule. In some examples, the implant is apoly(methyl methacrylate) (PMMA) IOL, and the incision has to beenlarged. In some examples, the implant is a foldable IOL made ofsilicone or acrylic and is folded either using a holder, folder, orinsertion device provided with the IOL. The IOL is inserted and placedin the posterior chamber in the capsular bag for in-the-bagimplantations.

The procedure includes 3150 applying excimer laser trabeculostomy (ELT)treatment to the patient. In various embodiments, ELT and cataractsurgery are performed through the same corneal incision. In someexamples, a physician creates about 10 ELT sites in an eye of thepatient after completing phacoemulsification in that eye.

The obstruction of aqueous outflow at the trabecular meshwork and innerwall of Schlemm's canal is the primary cause of elevated IOP inopen-angle glaucoma (OAG). Various embodiments use excimer laser toperforate the Schlemm's canal. Other lasers, such as ruby and argonlasers, cannot achieve a permanent perforation of the trabecularmeshwork to create an internal, rather than external, outflow channel.Though the photothermal and photodisruptive lasers were initiallysuccessful in puncturing the meshwork, the effect was short-lived due toinflammatory and healing responses. Excimer laser trabeculostomy (ELT)reestablishes the natural aqueous outflow of the eye without inciting ahealing response at the target tissue.

Ablation with excimer lasers causes almost no thermal damage, thereforeminimizing inflammation and the formation of scar tissue. A 308-nmxenon-chloride ultraviolet excimer laser causes minimal thermal damagecompared with visible or infrared lasers. Unlike argon and selectivelaser trabeculoplasty, ELT precisely excises tissue without causingthermal injury or scarring the surrounding tissue. ELT treatment thuscreates a long-term opening that connects the anterior chamber of theeye directly to Schlemm's canal. To avoid the corneal absorption oflaser radiation, an optical fiber is used to deliver the energy. Thefiber probe, or fiberoptic probe, is advanced through the incision andacross the anterior chamber of the eye to contact the trabecularmeshwork. A goniscope or endoscope may be used by the physician tovisualize placement of the fiber probe.

The physician applies pulsed photoablative energy. Typically, thephysician creates 10 sites in one or two inferior quadrants. A smallamount of bloody reflux from Schlemm's canal confirms each opening. Thefiber probe is removed from the eye. Notably, the IOP decreasesimmediately after administering the ELT procedure. Topical antibioticsand steroid drops are used by the patient for 1 to 2 weekspost-operatively.

After applying phaco and ELT treatments, a physician 3160 closes theincision. Secure closure of the incision is necessary to preventendophthalmitis. Typically, a physician uses sutures to close theincision. Some physicians place a suture in the incision and otherphysicians reserve a suture for when there is persistent leakage. Thenumber of sutures required also depends on the type of IOL implantedduring the phaco procedure. For example, a foldable IOL requires few orno sutures because the foldable IOL may be inserted through an incisionthat is smaller than required for insertion of a PPMA IOL.

Methods of the various embodiments include 3170 analyzing post-operativeresults and 3180 reporting results and scheduling post-operativefollow-up with the patient after surgery. For example, the physician'sanalysis may include observing a small amount of bloody reflux fromSchlemm's canal to confirm each opening. In turn, the physician mayreport the results to the patient, prescribe post-operative medication,such as topical antibiotics and steroid drops, and schedule a follow-uppost-operative visit with the patient.

FIG. 11 shows a flowchart of an embodiment 1401 for diagnosing andperforming an ELT procedure. As described herein, an ELT procedure maybe performed without performing a phaco treatment or in conjunction witha phaco treatment. Similarly the embodiment 1401 may be performedregardless of whether a phaco treatment is given to a patient.Specifically the method 1401 may be used to prophylactically treat apatient to prevent them from developing glaucoma and/or an elevatedintraocular pressure (TOP).

The embodiment 1401 includes, at 1402, performing a pre-operativeanalysis of a patient, where the patient is determined during thepre-operative analysis to have a congenital or otherwise elevated riskfor developing glaucoma or elevated TOP. The risk factors that may beconsidered during the pre-operative analysis at 1402 may include one ormore of age, family history, race, gender, presence of a comorbidity(e.g., presence of a condition that is associated with risk fordeveloping glaucoma and/or elevated TOP).

Because the ELT treatment has relatively high levels of success inperforating a patient's trabecular meshwork without significant risk ofdamage to the tissue surrounding the perforations, ELT treatments areconsidered relatively safe and typically have quick recoveries withoutcomplications. As such, since risks associated with ELT treatments arelow and positive outcomes are high, ELT procedures may be safelyperformed on patients that may not yet have glaucoma and/or elevatedTOP, but may be at risk of glaucoma and/or elevated TOP. In other words,since ELT procedures are less invasive, ELT treatments may be performedon more patients that have one or more risk factors for glaucoma and/orelevated TOP without high risk of side effects or failure of thetreatment over time.

During the pre-operative analysis, the risk factors assessed may be oneor more risk factors, where if the risk factor (or more than one riskfactor) is present, the patient may be considered to be at risk ofdeveloping glaucoma and/or elevated TOP. For example, if a patient is ator above a certain age, the patient may be determined to be at risk ofdeveloping glaucoma and/or elevated TOP and therefore may be qualify foran ELT procedure during the pre-operative analysis. For example, thepatient may be at or above age 40, at or above age 45, at or above age50, at or above age 55, at or above age 60, at or above age 65, at orabove age 70, at or above age 75, or at or above age 80 to be consideredat risk for glaucoma and/or elevated TOP. In various examples, thepatient may be considered at risk if they have a congenital risk that isassociated with higher incidences of glaucoma, such as if they are of aparticular race, such as African American or black, Latino, south Asianor Indian, East Asian (e.g., Chinese, Japanese, and/or Korean), etc. Acongenital risk may also be determined based on a family history ofglaucoma and/or elevated TOP. In various examples, the patient may beconsidered at risk if they are a particular gender. In various examples,the patient may be considered at risk if they have other illnesses orconditions present, such as ocular hypertension, obesity, diabetes, etc(e.g., comorbidities). In various examples the patient may be consideredat risk if they are a tobacco or alcohol user, or if their alcohol ortobacco use has occurred for a minimum threshold of years or if thefrequency of their alcohol or tobacco use is above a particularthreshold.

At 1404, if the patient has been determined to have a congenital orotherwise sufficient risk factor for developing glaucoma and/or elevatedTOP, the ELT procedure may be performed on the patient toprophylactically prevent the onset of glaucoma and/or elevated TOP basedon the pre-operative analysis and determination.

In various embodiments, the pre-operative analysis at 1402 may alsoinclude a genetic analysis or test of the patient. For example, apatients genetic cellular material (e.g., DNA, RNA) may be sampled andanalyzed to look for markers or indicators that a patient may be at riskof glaucoma and/or elevated TOP.

One risk factor may be race as discussed above. A certain type ofglaucoma called closed angle glaucoma may be more likely to occur inEast Asian (e.g., Chinese, Japanese, Korean) persons. As such, an ELTprocedure may be performed if a patient is East Asian (either with orwithout identification of another risk factor) due to a risk ofdeveloping closed angle glaucoma. In addition, certain aspects of an eyeof a patient may be measured or examined to see if the patient is atrisk of developing closed angle glaucoma (e.g., monitor or measure thethickness of the patient's lens of the eye and/or angle of the iris).Such aspects may represent a higher risk or indication of developingclosed angle glaucoma, and therefore may be considered a risk factor fordeveloping glaucoma and/or elevated TOP.

Angle-closure glaucoma, also called closed-angle glaucoma, occurs whenan iris of the eye bulges forward to narrow or block the drainage angleformed by the cornea and iris. As a result, fluid can't circulatethrough the eye and pressure increases. This is demonstrated in FIGS.12A and 12B. In FIG. 12A, fluid can move normally from the underside ofthe iris, between the iris and the lens to the topside of the iris, anddrain normally through the trabecular meshwork. When the fluid can drainnormally, IOP can stay at an appropriate level.

In FIG. 12B, a closed angle is shown that can increase IOP and causeglaucoma. In particular, the lens is thickened, causing it to press upagainst the iris and block flow of fluid from underneath the iris to thetopside of the iris. The iris may further bulge, which may further blockdrainage paths out of the trabecular meshwork. As such, fluid in the eyemay not drain properly and may cause elevated IOP and glaucoma. Bulgingof the iris, thickening of the lens, and buildup of pressure below theiris may further cause pressure on the Schlemm's canal through whichfluid may drain, thereby reducing the fluid that may flow throughSchlemm's canal.

In certain individuals, the lens of the eye may continue to grow andthicken as a person ages. As such, closed angle glaucoma risks may beassociated with certain races and certain ages of a patient duringpre-operative analysis. One method of treatment for closed angleglaucoma is through use of a phaco procedure, where the lens of the eyethat has thickened is replaced with an artificial lens that is thinner,and a path for fluid drainage between the lens and the iris, as well aspossibly between the iris and trabecular meshwork, may also be openedagain. In this way, the phaco procedure gets the iris to move downwardso that the trabecular meshwork may be accessed and therefore an ELTprocedure may be successful. As described herein, it may be desirable toperform phaco and ELT treatments during a same procedure. As such, whena patient is either identified as being at risk for closed angleglaucoma or is being treated for closed angle glaucoma, it may beadvantageous to perform an ELT treatment on the patient. In this way,drainage of fluid out of the eye may improve and a phaco procedure maybe delayed if not yet necessary, or the ELT and phaco procedures may beadvantageously performed together as described herein.

As such, according to the various embodiments described herein, ELT maybe performed with or without performing a phaco procedure based on thecondition of a patient and the risk factors present in the patient. Riskfactors such as congenital risk factors may be determined during apre-operative analysis of the patient and their eyes to determine if thepatient is at risk of developing glaucoma and/or elevated IOP, if thepatient already has elevated IOP but does not yet have glaucoma, etc. Inother words, an ELT treatment may be applied prophylactically to treatglaucoma even if the patient has not yet been diagnosed with glaucomaand/or without the patient actually having glaucoma. Similarly, if oneor more risk factors are identified as being present in the patient, andthe patient has not yet been identified as having elevated TOP, an ELTtreatment may still be performed on the patient due to the identifiedrisk factor(s).

In various embodiments, a specific risk factor may not even beidentified. The trabecular meshwork in every human eye becomes moreimpermeable with age. As such, after a particular age, an ELT proceduremay be applied to a patient regardless of specific congenital riskfactors. In other words, the ELT procedure may be applied completelyprophylactically, despite the absence of (or lack of knowledge of) anyparticular risk factors other than age. As such, the ELT procedure maybe used as a preventative measure, even before a patient has elevatedTOP or before any risk factor is identified in a patient.

FIG. 13 diagrams a schematic of system 200 according to variousembodiments. The system 200 includes an ELT instrument 201 and a phacoinstrument 221 communicatively coupled to a computer 205. The system 200optionally includes a server 209 and storage 213. Any of the ELTinstrument 201, phaco instrument 221, the computer 205, the server 209,and the storage 213 that are included may exchange data viacommunication network 217. Where methods of the various embodimentsemploy a client/server architecture, steps of methods of the variousembodiments may be performed using the server, which includes one ormore of processors and memory, capable of obtaining data, instructions,etc., or providing results via an interface module or providing resultsas a file. The server may be provided by a single or multiple computerdevices, such as the rack-mounted computers sold under the trademarkBLADE by Hitachi. In system 200, each computer may include at least oneprocessor coupled to a memory and at least one input/output (I/O)mechanism.

A processor generally includes a chip, such as a single core ormulti-core chip, to provide a central processing unit (CPU). A processormay be provided by a chip from Intel or AMD.

Memory can include one or more machine-readable devices on which isstored one or more sets of instructions (e.g., software) which, whenexecuted by the processor(s) of any one of the disclosed computers canaccomplish some or all of the methodologies or functions describedherein. A computer of the various embodiments may include one or moreI/O device such as, for example, one or more of a video display unit(e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)), analphanumeric input device (e.g., a keyboard), a cursor control device(e.g., a mouse), a disk drive unit, a signal generation device (e.g., aspeaker), a touchscreen, an accelerometer, a microphone, a cellularradio frequency antenna, and a network interface device, which can be,for example, a network interface card (NIC), Wi-Fi card, or cellularmodem. The system 200 may be used to perform methods described herein.Instructions for any method step may be stored in memory and a processormay execute those instructions.

FIG. 14 is a diagram of a treatment system 300 according to the variousembodiments. The system 300 is used to treat multiple eye conditions,such as cataracts and glaucoma. The treatment system 300 comprises aphacoemulsification (phaco) system 310 and an excimer lasertrabeculostomy (ELT) system 360. The phaco system 310 includes acontroller 320, ultrasound generator 330, irrigation source and/or pump340, and aspiration source and/or pump 350. The phaco system 310 may behoused in an instrument. An ultrasound probe may connect to the phacosystem and instrument for use during phaco treatment. The excimer lasersystem 360 comprises a controller 370, excimer laser 380, and gascartridge 390. The excimer laser system 360 may be contained in ahousing, and a fiber probe may connect to the housing for use during ELTtreatment.

FIG. 4 shows an embodiment of the excimer laser trabeculostomy (ELT)instrument 400. An excimer laser is contained in the housing 402. Thehousing has wheels 404 and is portable. The push-pull handle 405 assistswith portability of the ELT instrument 400. A foot pedal 414 extendsfrom the housing 402 and is operable to provide power for deliveringshots from the laser through the fiber probe 102, 104. A connector ofthe fiber probe 102, 104 connects to the excimer laser in the housing402 at the fiber connection port 406. The housing comprises aninteractive user interface 416. In some examples, the interactive userinterface 416 displays patient information, machine settings, andprocedure information. The housing 402 includes control buttons,switches, and dials, such as a fiber probe cap holder 408, an emergencystop button 410, and a power switch 412.

FIG. 5 shows a capped version of the fiber probe 500. FIG. 6 shows anembodiment of the probe 500 with the cap 514 removed, exposing thedelivery tip 506 of the probe 500. The probe 500 is a single use,disposable unit. In some embodiments, the fiber probe 500 has a tag thatdetermines operability. In some examples, a radio frequencyidentification (RFID) tag must match an RFID on the instrument in orderto operate. The probe 500 generally includes a laser transmitting memberand an illumination member as previously described herein, wherein eachare coupled to their respective sources (i.e., laser source 108 andlight source 110) by way of a connector 502 (elongated cord) extendingfrom the body of the probe 500 and having a connection assembly 504configured to be received within the connection port 406 of theinstrument 400. The probe 500 further includes a delivery tip 506 fromwhich laser energy (from the laser transmitting member) and visiblelight (from the illumination member) may be emitted. The probe 500includes a handheld body 508, which may include a finger grip 510 withridges or depressions 512. The body 508 of the handheld probe 500 may bemetal or plastic. The fiber tip 506 at the distal end of the probecomprises an optical fiber jacketed in metal, such as stainless steel ortitanium. The jacketed fiber at the distal end of the probe is insertedinto the trabecular meshwork of the eye. A foot pedal is depressed topower the laser. When powered, the laser delivers a shot from the laserthat travels through the optical fiber to the trabecular meshwork andSchlemm's canal.

FIG. 15 shows a phaco system or instrument 800. The phaco instrument 800has a housing 910 that houses the ultrasound generator. The housing 910is portable and has wheels 920. A foot pedal 930 extends from thehousing 910 and is used to provide energy from the ultrasound generatorto the ultrasound probe 950. A holder 940 extends from the housing 910to hold the ultrasound probe 950 when it is not in use. The ultrasoundprobe 950 is connected to the ultrasound generator through connector960. The phaco instrument includes an interactive display 970 andadditional controls 980. For example, the controls 980 may be controldials or buttons and may include a power switch and emergency stopswitch. The interactive display 970 may display irrigation flow rate,suction flow rate, and ultrasound frequency and amplitude.

FIG. 16 shows the ultrasound probe 1000 used during phaco. Theultrasound probe 1000 may also be referred to as a phaco probe, anultrasonic probe, or a phaco handpiece. The phaco probe connects to thephaco system with connector 1040, which may be a protective plasticsheath. The protective sheath of connector 1040 covers the irrigationline 1010, ultrasound power line 1020, and aspiration line 1030. Theconnector 1040 connects the phaco system with the body 1060 of the phacoultrasonic probe 1000. The body 1060 of the ultrasonic probe 1000optionally has a finger grip 1050 with ridges 1055. The phaco probe issterilized by any suitable method that provides sterilized equipmentsuitable for use on humans. In some embodiments, the phaco probe isdisposable. The body 1060 of the ultrasound probe 1000 has a tip 1070.The tip 1070 includes the needle 1095 and the irrigation sleeve 1085.The needle 1095 is made of titanium or steel. The needle has a beveledtip (e.g., at 0°, 15°, 30°, and 45° with respect to the tip). The phaconeedle operates at a frequency of 40 kHz with amplitude of 3/1000 of aninch. At the distal opening of the needle is the aspiration port 1090.The aspiration port 1090 communicatively coupled to the aspirationsource/pump and subsequently to a drain source. The needle also has oneor more irrigation ports 1080. The irrigation port 1080 iscommunicatively coupled to the irrigation source/pump. The siliconeirrigation sleeve 1085 or silicon material covers the phaco tip andprotects the cornea and iris from heat energy transmitted by the probe.In certain examples, the pumps used for irrigation and aspiration areselected from peristaltic pumps, Venturi pumps, and diaphragmatic pumps.

FIGS. 17-20 show embodiments of the foot pedal according to variousembodiments. In certain embodiments, the instrument comprises one footpedal for the phaco procedure and one foot pedal for the ELT procedure.The foot pedal has a number of positions. As shown in FIGS. 17-20 ,there are four positions. The initial position is when the foot pedal1100 is not depressed, as shown in FIG. 17 . In FIG. 18 , the foot pedal1200 is in a first position 1110 and is slightly depressed. In FIG. 19 ,the foot pedal 1300 is in a second position 1120 and is moderatelydepressed. In FIG. 20 , the foot pedal 1400 is in a third position 1130and is fully depressed.

In an embodiment, the foot pedal is used for the phaco procedure. In thefirst position, the phaco foot pedal provides irrigation only. In thesecond position, the phaco foot pedal provides irrigation andaspiration. In the third position, the phaco foot pedal providesirrigation, aspiration, and phaco power.

In an embodiment, the foot pedal is used for the ELT procedure. Eachdepression of the foot pedal may result in one shot from the laser. Forexample, when the foot pedal is depressed to the first position, asshown in FIG. 18 , one shot is fired from the laser. When the foot pedalis depressed to the second position, as shown in FIG. 19 , one shot isfired from the laser. When the foot pedal is depressed to the thirdposition, as shown in FIG. 20 , one shot is fired from the laser.Alternatively, the energy provided by the foot pedal may increase witheach position of the laser. For example, at the first position, one shotmay be fired from the laser, while the second position fires two shotsfrom the laser, and the third position fires three shots from the laser.

While FIGS. 4 and 15 show separate machines/systems for ELT and phacoprocedures, phaco and ELT systems may further be combined into a singlemachine according to the embodiments described herein. For example, FIG.21A shows a machine 1500 that includes components of both the ELT systemof FIG. 4 and the phaco system of FIG. 15 . Such a machine may take upless space in an operating room, which may be advantageous to allow anoperator and anyone else in the operating room more space to maneuver.In addition, such a system may be advantageous where, as describedherein, phaco and ELT treatments are performed together on the samepatient during a same operation or procedure. The operator may thereforenot have to move and switch between machines if they are using acombined machine as in FIG. 21A.

The machine 1500 of FIG. 21A shows a single pedal 414 that may beconfigured to operate and or work with both of the probe 950 for phacotreatments and the probe 102, 104 for the ELT treatments. In suchembodiments, the operator may be able to toggle a switch or otherwisemake an input into the machine 1500 to indicate whether they are usingthe ELT probe 102, 104 or the phaco probe 950. In another example, themachine 1500 may be programmed or configured to determine which probe isbeing used by the operator. For example, the handle of the probes may beequipped with a touch sensor so that only the probe that is being heldby the operator may be operated using the pedal 414. In another example,the probes may be further actuated by a button or other switch on theprobe in combination with the pedal, such that the pedal may onlycontrol a probe on which a button or other switch is depressed orotherwise activated (e.g., like a safety). In another example of theprobes being actuated with a button on the handle and the pedal 414, thebutton on the handle and the pedal may be used for different functions.For example, the pedal may be used to set the power delivered by thelaser/probe, and a button on the handle may be used to actually delivera shot of energy per the setting of the pedal. As such, the machine 1500may not accidentally fire a laser for a probe not in use because abutton on the probe may still have to be actuated in order to get thegiven laser/probe to fire. In various embodiments, other combinedmachines for ELT and phaco treatments may have more than one pedal, suchas one pedal used for the phaco system/treatments and one pedal usedspecifically for the ELT system/treatments.

FIG. 21B shows another example of a combined ELT/phaco machine 981. Themachine 981 may advantageously have only a single power cord 982 forplugging into external power. The machine 981 may include a phaco unit983 and an ELT unit 984. Each of the phaco and ELT units 983 and 984 maybe at a height that is convenient for a user to plug in and/or removeprobes from the machine. In the example of FIG. 21B, the phaco unit 983and the ELT unit 984 are at different heights, but still oriented towarda top of the machine 981 for ease of access by a user. In otherembodiments, the phaco unit 983 and the ELT unit 984 may be oriented ata same height. The ELT unit 984 may include a display 985, a receiver987 to connect to a fiber probe, and an energy monitor 988 configured toreceive the distal end of a fiber probe, so that laser light emitted bythe probe may be received by a sensor of the machine 981 to calibratethe laser power being emitted by a probe. When inserted into the energymonitor, the distal end of the probe may have a sterile adapter attachedto it that may be discarded after calibration. In this way, the distalend of the probe that will be inserted into an eye does not come intocontact with the machine 981 or the energy monitor 988. The energymonitor 988 may also have a shutter, so that the sensor is only exposedwhen the probe is inserted and the shutter is therefore pushed back. Invarious embodiments, a single sensor and port for calibrating a laserprobe may be used for both an excimer laser for the ELT procedure and alaser and probe used in a phaco procedure. A section 986 shown inphantom of the machine 981 may also include other internal aspects ofthe machine, such as vitrectomy components, irrigation/aspirationcomponents, feeds for both ELT and phaco lasers, etc. The section 986may also include or may be an access panel that allows the machine 981to be serviced as desired.

In various embodiments, an excimer laser (and any components associatedtherewith described herein) for performing an ELT (e.g., an ELT laser,ELT components) may be combined with different components than thoseassociated with a phacoemulsification unit. For example, the excimer orELT components may be combined with any other components that may beused to treat a cataract or other eye condition. For example, theexcimer or ELT components may also be located in a same housing as,powered by a same cord/outlet as, etc. components for a femtolasercataract surgery. In such an example, a femtolaser is used to create anopening in a front layer of the lens of an eye, and the laser is alsoused to break up a cloudy lens that has the cataract(s) and then may besuctioned out. As such, the femtolaser and suction components may beincluded in a same housing as the excimer or ELT components similar tothe embodiments with ELT and phacoemulsification components describedabove. As a result, a femtolaser treatment for cataracts may also becombined with an ELT procedure, similar to the embodiments describedherein that combine an ELT procedure with a phacoemulsificationprocedure.

Such machines may save space in an operating room and therefore increaseefficiency during procedures performed on a patient. In variousembodiments, an ELT laser that fits into existing phaco machines (orphaco machines designed to house other laser components) may also bemanufactured, and then inserted into a phaco machine. Such a process mayinclude inserting the ELT components, fixing them to the phaco machinestructure, and connecting the ELT components to a power output or bus ofthe phaco machine.

Excimer Laser Fiber Illumination

In current laser trabeculostomy procedures, a surgeon utilizes a goniolens, a special contact lens prism, held over the eye, in combinationwith light, in order to visualize the working end of the laser fiberwhen positioning the laser fiber relative to the trabecular meshwork.

While a surgeon may have some view of the target site (i.e., thetrabecular meshwork), the combination of the gonio lens and the currentlight source relied upon for illuminating the target site is inadequate.In particular, current procedures rely on an external beam of light(from a slit lamp) in an attempt to illuminate the anterior chamberangle where the cornea and the iris meet (i.e., the location of thetrabecular meshwork). However, the external light source may fail toprovide a comprehensive view within the eye and is limiting. As such, asurgeon is unable to visually verify, with confidence, the position ofthe laser relative to the trabecular meshwork, the effectiveness oflaser treatment to any given portion of the meshwork, as well asdrainage of the aqueous humor upon laser treatment. For example, withoutproper visualization, a surgeon may position the laser too close or toofar from the trabecular meshwork and/or position the laser at improperangles relative to the trabecular meshwork, resulting in unintendedcollateral tissue damage or the creation of channels that inadequate anddo not provide the desired drainage. As a result, the laser treatmentmay be inadequate, as the desired drainage may not be achieved, and thuspatients may require additional post-operative procedures to lower theintraocular pressure.

Systems of the embodiments herein include a laser probe for performingan intraocular procedure. The laser probe is a single use, disposableprobe configured to be coupled to a laser source and transmit laserenergy from the laser source to a target tissue for treatment thereof.The laser probe includes both a laser transmitting member and a lightemitting member in a single component. In particular, the laser probeincludes a fiber optic core comprising a delivery tip for transmittinglaser energy from the laser source to the target tissue during aprocedure. The laser probe further includes a light emitting memberproviding illumination in a field of view proximate to the delivery tipof the fiber core, thereby providing a clear field of view for a surgeonduring laser treatment of the target tissue.

The laser probe of various embodiments herein may be particularly wellsuited for a laser trabeculostomy procedure. During such a procedure, itis critical that the surgeon has a clear field of view within the eye,particularly of the anterior chamber angle where the cornea and the irismeet so that the position of the laser relative to the trabecularmeshwork can be clearly visualized. A surgeon may guide the delivery tipof the fiber optic core of the laser probe through a corneal incision ofthe eye and towards the trabecular meshwork. The light emitting memberemits a visible light signal within the eye and proximate to thedelivery tip, thereby illuminating a field of view in which the surgeoncan better visualize positioning of the delivery tip and subsequenttransmission of laser energy upon the trabecular meshwork. By providinga laser probe with an integrated lighting member, illumination isprovided internally (i.e., within the eye), as opposed to currentprocedures which rely on an external light source, and thus provides amuch more comprehensive view within the eye and the improved view of thetarget location. By providing an improved view, a surgeon is able tobetter position the delivery tip relative to the trabecular meshwork soas to achieve optimal photoablation and channel formation in themeshwork and/or Schlemm's canal. In particular, the orientation andpositioning of the delivery tip is critical when attempting to createoptimal channel formation in the tissue, particularly when attempting toachieve placement of channels in the meshwork relative to Schlemm'scanal, which will provide optimal drainage. Furthermore, the surgeon isable to visually verify, with more confidence, the effectiveness of thelaser treatment by visualizing drainage of the aqueous humor as a resultof the laser treatment.

In various embodiments herein, an excimer laser probe may be providedfor performing an intraocular procedure. The intraocular procedure mayinclude a laser trabeculostomy and thus the target tissue includestrabecular meshwork and/or Schlemm's canal. However, it should be notedthat a laser probe consistent with the present disclosure can be used inany laser treatment of eye conditions, including, but not limited to,diabetic eye diseases, such as proliferative diabetic retinopathy ormacular oedema, cases of age-related macular degeneration, retinaltears, and retinopathy of prematurity, and laser-assisted in situkeratomileusis (LASIK) to correct refractive errors, such asshort-sightedness (myopia) or astigmatism.

The laser probe may include a fiber optic core comprising a proximal endcouplable to an excimer laser source and a distal end comprising adelivery tip for transmitting laser energy from said excimer lasersource to a target tissue for treatment thereof. The laser probe furtherincludes an illumination member for providing illumination in a field ofview proximate to said delivery tip of said fiber core.

In various embodiments, the illumination member comprises an opticalfiber for receipt of a light signal from an illumination source. Theillumination source provides a light signal within the visible lightspectrum. Accordingly, the illumination source may include, but is notlimited to, an incandescent light source, a fluorescent light source, ahalogen light source, a high-intensity discharge light source, a metalhalide light source, and a light emitting diode (LED) light source.

In various embodiments, the optical fiber is coaxially aligned with thefiber core. In other embodiments, the optical fiber is adjacent to thefiber core. The laser probe further includes an outer jacket surroundingthe optical fiber and fiber core.

Another aspect of the various embodiments described herein may be anexcimer laser system for performing an intraocular procedure. Again, theintraocular procedure may include a laser trabeculostomy and thus thetarget tissue includes trabecular meshwork and/or Schlemm's canal. Theexcimer laser system includes an excimer laser source, an illuminationsource, and a disposable, single use probe operably couplable to theexcimer laser source and illumination source and configured to be usedin the intraocular procedure. The laser probe includes a fiber opticcore comprising a proximal end couplable to the excimer laser source anda distal end comprising a delivery tip for transmitting laser energyfrom said excimer laser source to a target tissue for treatment thereof.The laser probe further includes an illumination member for receiving anillumination signal from the illumination source and for providingillumination in a field of view proximate to said delivery tip of saidfiber core.

In various embodiments, the illumination member comprises an opticalfiber for receipt of a light signal from an illumination source. Theillumination source provides a light signal within the visible lightspectrum. Accordingly, the illumination source may include, but is notlimited to, an incandescent light source, a fluorescent light source, ahalogen light source, a high-intensity discharge light source, a metalhalide light source, and a light emitting diode (LED) light source.

In various embodiments, the optical fiber is coaxially aligned with thefiber core. In other embodiments, the optical fiber is adjacent to thefiber core. The laser probe further includes an outer jacket surroundingthe optical fiber and fiber core.

In various embodiments, a laser probe may provided. The laser probe maybe a single use, disposable probe configured to be coupled to a lasersource and transmit laser energy from the laser source to a targettissue for treatment thereof. The laser probe includes both a lasertransmitting member and an illumination member in a single component. Inparticular, the laser probe includes a fiber optic core comprising adelivery tip for transmitting laser energy from the laser source to thetarget tissue during a procedure. The laser probe further includes alight emitting member providing illumination in a field of viewproximate to the delivery tip of the fiber core, thereby providing aclear field of view for a surgeon during laser treatment of the targettissue.

The laser probe of various embodiments may be suited for intraocularprocedures in which laser treatment of target tissues is desired. Inparticular, the laser probe of various embodiments may be used fortreating glaucoma and useful in performing a laser trabeculostomy.However, it should be noted that a laser probe consistent with thepresent disclosure can be used in any laser treatment of eye conditions,including, but not limited to, diabetic eye diseases, such asproliferative diabetic retinopathy or macular oedema, cases ofage-related macular degeneration, retinal tears, and retinopathy ofprematurity, and laser-assisted in situ keratomileusis (LASIK) tocorrect refractive errors, such as short-sightedness (myopia) orastigmatism.

During a laser trabeculostomy procedure, it is critical that the surgeonhas a clear field of view within the eye, particularly of the anteriorchamber angle where the cornea and the iris meet so that the position ofthe laser relative to the trabecular meshwork can be clearly visualized.By using the laser probe, a surgeon may guide the delivery tip of thefiber optic core of the laser probe through a corneal incision of theeye and towards the trabecular meshwork. The light emitting member emitsa visible light signal within the eye and proximate to the delivery tip,thereby illuminating a field of view in which the surgeon can visualize,with the aid of a gonio lens, positioning of the delivery tip andsubsequent transmission of laser energy upon the trabecular meshwork. Byproviding a laser probe with an integrated lighting member, illuminationis provided internally (i.e., within the eye), as opposed to currentprocedures which rely on an external light source, and thus provides amuch more comprehensive view within the eye and the improved view of thetarget location. By providing an improved view, a surgeon is able tobetter position the delivery tip relative to the trabecular meshwork soas to achieve optimal photoablation and channel formation in themeshwork and/or Schlemm's canal. In particular, the orientation andpositioning of the delivery tip is critical when attempting to createoptimal channel formation in the tissue, particularly when attempting toachieve placement of channels in the meshwork relative to Schlemm'scanal, which will provide optimal drainage. Furthermore, the surgeon isable to visually verify, with more confidence, the effectiveness of thelaser treatment by visualizing drainage of the aqueous humor as a resultof the laser treatment.

As discussed above, FIG. 4 shows an embodiment an excimer laser system100; FIG. 5 shows an embodiment of a probe 500 for use with the excimerlaser system 100, illustrating the probe 500 having a capped, distaldelivery tip 506; and FIG. 6 shows an embodiment of the probe 500 withthe cap 514 removed, exposing the delivery tip 506 of the probe 500.

FIGS. 22 and 23 show cross-sectional views of the probe 500 taken alongline A-A and line B-B of FIG. 6 , respectively. As shown, the lasertransmitting member may include fiber optic core 518 that runs throughthe fiber probe 500 and forms part of the connector 502. Similarly, theillumination member may include an optical fiber 520 that also runsthrough the fiber probe 500 and forms part of the connector 502. Aprotective sheath 516 surrounds the fiber optic core 518 and opticalfiber 520. In some examples, the protective sheath 516 is a protectiveplastic or rubber sheath. The fiber optic core 518 and optical fiber 520further form part of the delivery tip 506 of the probe 500. A metaljacket 522 surrounds the fiber optic core 518 and optical fiber 520. Insome instances, a stainless steel jacket 522 surrounds and protects thefiber optic core 518 and optical fiber 520. As illustrated, in someembodiments, the optical fiber 520 is coaxially aligned with the fiberoptic core 518, either surrounding the core 518, or, in otherembodiments, the core 518 may surround the fiber 520. In otherembodiments, the optical fiber 520 is adjacent to the fiber optic core518.

FIG. 24 shows an enlarged view of the delivery tip 502 of a probe 500emitting visible light (via emission from the optical fiber 520 uponreceipt of light signals from the light source 110) and emitting laserenergy (via emission from the fiber optic core 518 upon receipt of laserpulses from the laser source 108) for photoablation of a target tissue.

FIGS. 25 and 26 show alternate embodiments of a probe, withcross-sectional views 530 and 536 similar to FIGS. 22 and 23 of theprobe 500 taken along line A-A and line B-B of FIG. 6 , respectively. Asshown, the laser transmitting member may include a fiber optic core 534that runs through the fiber probe 500 and forms part of the connector502. In this embodiment, visible light from the light source 110 of thelaser system 100 may be transmitted through the fiber optic core 534along with the laser used for a treatment for glaucoma. That is, invarious embodiments, the laser system 100 may not have a separateillumination member 104 in its probe member 102. Rather, the probemember 102 may have a single fiber optic core (e.g., the fiber opticcore 534) through which both excimer laser light and visible light forilluminating a treatment area inside the eye may pass. The visible lightand excimer laser light may pass through the fiber optic core 534without interfering with one another due to their different wavelengths,or may interfere with one another to a small enough degree that the useof the excimer laser for the eye treatment may not be impacted. In thisway, both the excimer laser light and the visible light may pass througha single fiber optic core 534.

In addition to reducing the cost of the probes and fiber optics thereinby having one instead of two optical fibers, the connector 502(elongated cord) attached to a probe may be easier to manipulate havingonly one optical fiber inside instead of two. Such a configuration maymake the connector 502 (elongated cord) less stiff, and may reduce thediameter, weight, etc. of the connector 502. In addition, the visiblelight output at the delivery tip 502 of the probe 500 may be even closerto where the laser is being applied for the laser trabeculostomytreatment. In this way, the light emitted by a single fiber optic core534 through which both the excimer laser light and visible light ispassed may more effectively illuminate a treatment area within the eye.A protective sheath or metal jacket 532 may also surround the fiberoptic core 534 in FIG. 25 . In some examples, the protective sheath 532is a protective plastic or rubber sheath. A protective sheath or metaljacket 538 may surround the fiber optic core 534 in FIG. 26 . In variousembodiments, the protective sheath or metal jacket 532 may be astainless-steel jacket and may surround and protect the fiber optic core534. As illustrated, in various embodiments, the protective sheath ormetal jacket 532 is coaxially aligned with the fiber optic core 534. Assuch, the protective sheath or metal jacket 532 is adjacent to the fiberoptic core 534.

In various embodiments, different types of light may be used. Forexample, visible white light may be used to illuminate the angledstructure of the trabecular meshwork for better visibility whileapproaching a fiber probe toward the trabecular meshwork before it comesinto contact with the tissue of the trabecular meshwork. Visible whitelight may also illuminate structure in front of the delivery tip of thefiber probe while the probe is in contact with tissue, such as thetrabecular meshwork. In various embodiments, specific wavelengths ofvisible light may be used in addition to or in the alternative tovisible white light. For example, light of a wavelength that is highlyabsorptive by blood may be used, so that the operator may be able tomore easily identify and/or visualize Schlemm's canal and other bloodvessels present in the eye. Similarly, light of a wavelength that is nothighly absorbed by blood may be used to visualize blood structure (e.g.,a sort of negative picture of what would be shown with light that ishighly absorptive by blood). Such wavelengths may offer an operatorbetter visibility into structures of the eye, including vessels andother structures that are not on the surface of portions of the eye.

The laser probe may be suited for intraocular procedures in which lasertreatment of target tissues is desired. In particular, the laser probemay be used for treating glaucoma and useful in performing a lasertrabeculostomy. However, it should be noted that a laser probeconsistent with the present disclosure can be used in any lasertreatment of eye conditions, including, but not limited to, diabetic eyediseases, such as proliferative diabetic retinopathy or macular oedema,cases of age-related macular degeneration, retinal tears, andretinopathy of prematurity, and laser-assisted in situ keratomileusis(LASIK) to correct refractive errors, such as short-sightedness (myopia)or astigmatism.

During a laser trabeculostomy procedure, it is critical that the surgeonhas a clear field of view within the eye, particularly of the anteriorchamber angle where the cornea and the iris meet so that the position ofthe laser relative to the trabecular meshwork can be clearly visualized.By using the laser probe, a surgeon may guide the delivery tip of thefiber optic core of the laser probe through a corneal incision of theeye and towards the trabecular meshwork. The light emitting member emitsa visible light signal within the eye and proximate to the delivery tip,thereby illuminating a field of view in which the surgeon can visualize,with the aid of a gonio lens, positioning of the delivery tip andsubsequent transmission of laser energy upon the trabecular meshwork. Byproviding a laser probe with an integrated lighting member, illuminationis provided internally (i.e., within the eye), as opposed to currentprocedures which rely on an external light source, and thus provides amuch more comprehensive view within the eye and the improved view of thetarget location. By providing an improved view, a surgeon is able tobetter position the delivery tip relative to the trabecular meshwork soas to achieve optimal photoablation and channel formation in themeshwork and/or Schlemm's canal. In particular, the orientation andpositioning of the delivery tip is critical when attempting to createoptimal channel formation in the tissue, particularly when attempting toachieve placement of channels in the meshwork relative to Schlemm'scanal, which will provide optimal drainage. Furthermore, the surgeon isable to visually verify, with more confidence, the effectiveness of thelaser treatment by visualizing drainage of the aqueous humor as a resultof the laser treatment.

Authentication Systems and Methods for an Excimer Laser System

In the medical industry, there are many surgical devices, instrumentsand systems comprised of individual components that must work togetherproperly to ensure treatment is performed safely and as intended. Forexample, medical laser systems are used to treat various conditions invarious practice areas (i.e., urology, neurology, otorhinolaryngology,general anesthetic ophthalmology, dentistry, gastroenterology,cardiology, gynecology, and thoracic and orthopedic procedures). Medicallaser systems consist of a laser unit, which generates laser radiation,and a separate laser probe having an optical fiber adapted to directlaser radiation from the laser, through the fiber and to the treatmentarea.

Specific components of a laser system can be designed by a manufacturerto be utilized with other specific components. For example, there are avariety of medical optical fibers available in the marketplace that canbe used with laser systems. Currently available laser systems mayprovide laser light at various wavelengths and thus may be used forparticular purposes and procedures. As such, optical fibers to be usedwith these laser systems may have varying sizes (diameter, length,etc.), be made of various materials, operate at various temperatures,operate at various wavelengths, and have physical characteristics (e.g.,bend radii). Specific components of a laser system can be designed by amanufacturer to be utilized with other specific components. For example,there are many varieties of medical optical fibers available in themarketplace that can be used with laser systems that are used in medicalprocedures. Furthermore, the manufacturer of one component may alsomanufacture other components of a laser system, or may certify thatthese other components can be used with the manufacturer's owncomponents.

Prior to beginning a medical procedure, it is important that the properoptical fiber be connected to the laser unit that is to be used for themedical procedure. Oftentimes, the manufacturer of the laser unitrecommends usage of particular brands of optical fibers and/orparticular optical fibers with the laser unit. When one of thecomponents being used is not a certified product, the full capabilitiesof the system may not be achieved and may further cause malfunctions,endangering patient safety. For example use of an improper optical fibercan result in damage to the equipment, delay in conducting a medicalprocedure until the proper optical fiber is obtained, and/or result inthe potential for an ineffective, damaging, or potentiallylife-threatening medical procedure.

The various embodiments provides a system for authenticating laserprobes for use with a laser system. In such a system, the elementsgenerally include a laser unit and single-use, disposable laser probesto be coupled to the laser unit, each laser probe having an opticalfiber adapted to direct laser radiation from the laser unit, through thefiber, and to the treatment area. The laser unit comprises a controlsystem for operating the laser unit, including controlling output oflaser radiation to a laser probe coupled to the laser unit. The laserunit further includes structure(s) configured to authenticate any givenlaser probe to determine whether the laser probe is suitable and/orauthorized to operate with the laser unit. In particular, the laser unitincludes an RFID reader for reading data embedded in an RFID tagassociated with the laser probe upon attachment of the laser probe tothe laser unit. The data from the RFID tag is analyzed by the controlsystem and a determination is made as to whether the laser probe isauthentic (i.e., suitable for use with the laser unit). In the eventthat the laser probe is determined to be authentic, the control systemallows for transmission of laser radiation to the laser probe and thus aprocedure can be performed using the laser probe. In the event that thelaser probe is determined to not be authentic, the control systemprevents transmission of laser radiation to the laser probe.

The authentication analysis is based on a correlation of the RFID tagdata with known, predefined authentication data stored in a database,either locally in the laser unit, or stored in a remote database. Theknown, predefined authentication data is controlled by theowner/manufacturer of the laser unit, such that the owner/manufacturercan determine what laser probes are to be used with the laser unit. Theowner/manufacturer may set a specific authentication key or provide forspecific identity numbers that are proprietary to theowner/manufacturer. As such, the RFID tag data for any given laser probemust include a corresponding unique identifier (i.e., authentication keyor identity number) in order to be deemed authentic. The RFID tag datamay include other information and/or characteristics associated with thelaser probe and optical fiber. For example, in some embodiments, theRFID tag data further includes operational history information of thelaser probe. As such, in some embodiments, it is further possible toutilize the control system to deauthenticate a laser probe based onoperational history, such as in the event that the probe has alreadybeen used and/or reached the suggested maximum number of laser pulses,thereby preventing further use of the laser probe with the laser unit.

Accordingly, the authentication system of the various embodimentsensures that only authorized laser probes are able to be used with thelaser unit. The authentication ensures that only those laser probesrecommended and authorized by a manufacturer are to be used, therebyensuring that the laser system functions as intended and patient safetyis maintained. The authentication further protects against the use ofcounterfeit components. As counterfeit proprietary components becomemore prevalent, the need to authenticate original products becomesincreasingly necessary. By embedding RFID directly into the laser probeand utilizing RFID technology for authentication, manufacturers can foilcounterfeiters and secure recurring revenue streams, which may otherwisebe lost due to counterfeit products.

The various embodiments provide a system for authenticating laser probesfor use with a laser system. In such a system, the elements generallyinclude a laser unit and single-use, disposable laser probes to becoupled to the laser unit, each laser probe having an optical fiberadapted to direct laser radiation from the laser unit, through thefiber, and to the treatment area. The laser unit comprises a controlsystem for operating the laser unit, including controlling output oflaser radiation to a laser probe coupled to the laser unit. The laserunit further includes structure(s) configured to authenticate any givenlaser probe to determine whether the laser probe is suitable and/orauthorized to operate with the laser unit. In particular, the laser unitincludes an RFID reader for reading data embedded in an RFID tagassociated with the laser probe upon attachment of the laser probe tothe laser unit. The data from the RFID tag is analyzed by the controlsystem and a determination is made as to whether the laser probe isauthentic (i.e., suitable for use with the laser unit). In the eventthat the laser probe is determined to be authentic, the control systemallows for transmission of laser radiation to the laser probe and thus aprocedure can be performed using the laser probe. In the event that thelaser probe is determined to not be authentic, the control systemprevents transmission of laser radiation to the laser probe.

Accordingly, the authentication system of the various embodimentsensures that only authorized laser probes are able to be used with thelaser unit. The authentication ensures that only those laser probesrecommended and authorized by a manufacturer are to be used, therebyensuring that the laser system functions as intended and patient safetyis maintained. The authentication further protects against the use ofcounterfeit components. As counterfeit proprietary components becomemore prevalent, the need to authenticate original products becomesincreasingly necessary. By embedding RFID directly into the laser probeand utilizing RFID technology for authentication, manufacturers can foilcounterfeiters and secure recurring revenue streams, which may otherwisebe lost due to counterfeit products.

The laser unit and laser probe of various embodiments may be suited forintraocular procedures in which laser treatment of target tissues isdesired. In particular, the laser probe and laser unit of variousembodiments may be used for treating glaucoma and useful in performing alaser trabeculostomy. However, it should be noted that a laser probeconsistent with the present disclosure can be used in any lasertreatment of various conditions, including other eye conditions (i.e.,diabetic eye diseases, such as proliferative diabetic retinopathy ormacular oedema, cases of age-related macular degeneration, retinaltears, and retinopathy of prematurity, and laser-assisted in situkeratomileusis (LASIK) to correct refractive errors, such asshort-sightedness (myopia) or astigmatism) as well as other conditionsin general and other practice areas (non-ocular practice areas).

FIG. 27 diagrams an excimer laser system, including a laser unit system4100 and a laser probe 4200 to be attached to the laser unit system4100. The system 4100 includes an RFID reader 4102, a controller 4104(also referred to herein as a “control system 4104”), and a laser source4106. The laser probe 4200 includes an RFID tag 4202 and a fiber core4204. As will be described in greater detail herein, many of thecomponents of the laser unit system 4100 may be contained in a housing,such as a moveable platform, to be provided in a setting in which theprocedure is to be performed (e.g., operating room, procedure room,outpatient office setting, etc.) and the probe 4200 may connect to thehousing for use during treatment. Upon coupling the probe 4200 to thehousing, the fiber core 4204 is coupled to the laser source 4106 andadapted to direct laser radiation from the laser source 4106, throughthe fiber, and to the treatment area.

The laser source 4106 may include an excimer laser 4108 and a gascartridge 4110 for providing the appropriate gas combination to thelaser 4106. The excimer laser 4106 is a form of ultraviolet laser thatgenerally operates in the UV spectral region and generates nanosecondpulses. The excimer gain medium (i.e., the medium contained within thegas cartridge 4110) is generally a gas mixture containing a noble gas(e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine orchlorine). Under the appropriate conditions of electrical stimulationand high pressure, a pseudo-molecule called an excimer (or in the caseof noble gas halides, exciplex) is created, which can only exist in anenergized state and can give rise to laser light in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 4108of the present system 4100 is an XeCl excimer laser and emits awavelength of 308 nm.

The controller 4104 provides an operator (i.e., surgeon or other medicalprofessional) with control over the output of laser signals (from thelaser source 4106 to the fiber core 4204) and, in turn, control over thetransmission of laser energy from the fiber core 4204 of the probe 4200.However, prior to providing an operator with control over laser output,the laser probe 4200 undergoes an authentication procedure to determinewhether the laser probe 4200 is in fact suitable for use with the laserunit system 100. In particular, upon coupling the laser prober 4200 tothe system 4100, the RFID reader 4102 reads data embedded in the RFIDtag 4202 of the laser probe 4200, wherein such RFID tag data is analyzedto determine authenticity of the laser probe 4200.

FIG. 28 diagrams the laser system 4100 and authentication of a laserprobe 4200 to be used with the laser system 4100. The data from the RFIDtag is read by the RFID reader, and then analyzed by the controller4104. A determination is made as to whether the laser probe is authentic(i.e., suitable for use with the laser unit) based on the authenticationanalysis. In the event that the laser probe is determined to beauthentic, the controller 104 allows for transmission of laser radiationto the laser probe 4200 and thus a procedure can be performed using thelaser probe 4200. In the event that the laser probe is determined to notbe authentic, the controller 4104 prevents transmission of laserradiation to the laser probe 4200.

The controller 4104 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 4104 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the laser system 4100 as described herein, includingcontroller laser and/or illumination output.

The authentication analysis is based on a correlation of the RFID tagdata with known, predefined authentication data stored in a database,either a local database (i.e., probe database 4114) forming part of thelaser unit system 4100, or a remote database hosted via a remote server4300 (i.e., probe database 4302). For example, in some embodiments, thesystem 4100 may communicate and exchange data with a remote server 4300over a network. The network may represent, for example, a private ornon-private local area network (LAN), personal area network (PAN),storage area network (SAN), backbone network, global area network (GAN),wide area network (WAN), or collection of any such computer networkssuch as an intranet, extranet or the Internet (i.e., a global system ofinterconnected network upon which various applications or service runincluding, for example, the World Wide Web).

The known, predefined authentication data stored in the database(database 4114 or database 4302) may be controlled by theowner/manufacturer of the laser unit 4100, for example, such that theowner/manufacturer can determine what laser probes are to be used withthe laser unit. For example, the owner/manufacturer may set a specificauthentication key or provide for specific identity numbers that areproprietary to the owner/manufacturer. As such, the RFID tag data forany given laser probe must include a corresponding unique identifier(i.e., authentication key or identity number) in order to be deemedauthentic.

One approach to uniquely identifying a laser probe is to authenticatethe probe by using a private key. In such an approach, both the lasersystem 4100 and the RFID tag 4202 are taught an identical key. The RFIDtag 4202 and laser system 4100 then operate in conjunction toauthenticate the key. More specifically, the laser system 4100 generatesa random, unique challenge number. The RFID tag 4202 uses thischallenge, in combination with the key to generate a response of anauthentication code. The method for generating this code (known as ahash function) masks the value of the key. Another approach to uniquelyidentifying a laser probe is to use unique and unchangeable identitynumbers. This approach can be used if there is a region of memory (e.g.,a serial or model number), that can only be written by the RFIDmanufacturer. The protection is realized by ensuring that themanufacturer only provides tags with legal identification numbers, whichprevents simple duplication of legitimate tags.

The RFID tag data may include other information and/or characteristicsassociated with the laser probe and optical fiber. For example, in someembodiments, the RFID tag data further includes operational historyinformation of the laser probe. As such, in some embodiments, it isfurther possible to utilize the controller 4104 to deauthenticate alaser probe based on operational history, such as in the event that theprobe has already been used and/or reached the suggested maximum numberof laser pulses, thereby preventing further use of the laser probe withthe laser unit.

As generally understood, RFID technology uses electromagnetic fields toautomatically identify and track tags attached to objects. As previouslynoted, the RFID tag associated with the laser probe containselectronically-stored information. The RFID tag may either be read-only,having a factory-assigned serial number that is used as a key into adatabase, or may be read/write, where object-specific data can bewritten into the tag by the system user. Field programmable tags may bewrite-once, read-multiple; “blank” tags may be written with anelectronic product code by the user. The RFID tag contains at leastthree parts: an integrated circuit that stores and processes informationand that modulates and demodulates radio-frequency (RF) signals; asensor configured to collect DC power from the incident reader signal;and an antenna for receiving and transmitting the signal. The taginformation is stored in a nonvolatile memory. The RFID tag includeseither fixed or programmable logic for processing the transmission andsensor data, respectively.

The RFID reader transmits an encoded radio signal to interrogate thetag. The RFID tag receives the message and then responds with itsidentification and other information. This may be only a unique tagserial number, or may be product-related information such as a stocknumber, lot or batch number, production date, or other specificinformation. Since tags have individual serial numbers, the RFID systemdesign can discriminate among several tags that might be within therange of the RFID reader and read them simultaneously.

In some embodiments, the RFID tag may be a passive tag, which collectsenergy from the RFID reader of the laser system interrogating radiowaves. In some embodiments, the RFID tag may be an active tag, whichincludes a local power source (e.g., a battery) and may operate hundredsof meters from the RFID reader of the laser system. FIG. 4 shows anexample excimer laser unit that may be used in accordance with variousembodiments. The RFID reader 4102, controller 4104, and laser source4106 may be contained within a housing 402. It should further be notedthat the RFID reader 4102 may be located in proximity to the connectionport 406 to allow reading of data from the RFID tag 4202 that isprovided on a connecting end of the laser probe 4200.

FIG. 29 shows an embodiment of a probe 500 similar to that of FIG. 6 ,except the connection assembly may additionally have an RFID tagembedded therein or attached thereto. For example, the RFID tag 4202 isprovided on the connection assembly 504, such that, upon coupling theconnection assembly 504 to the connection port 406 of the laser unitsystem 100, data embedded in the RFID tag 4202 can be read by the RFIDreader 4102.

FIGS. 30 and 31 show cross-sectional views of the probe 500 taken alongline A-A and line B-B of FIG. 29 , respectively. As shown, a fiber opticcore 518 runs through the probe 500 and forms part of the connector 502.A protective sheath 516 surrounds the fiber optic core 518. In someexamples, the protective sheath 516 is a protective plastic or rubbersheath. The fiber optic core 518 further form part of the delivery tip506 of the probe 500. A metal jacket 520 surrounds the fiber optic core518 and optical fiber 520. In some instances, a stainless steel jacket520 surrounds and protects the fiber optic core 518.

FIG. 32 shows an embodiment a laser probe 500 attached to a laser unitsystem 100. As previously described, upon attachment of the laser probe500 to the system 100 (i.e., coupling between the connection assembly504 of the probe 500 and connection port 406 of the system 400), theRFID reader 4102 reads data embedded in the RFID tag associated withconnection assembly 504. FIG. 33 shows an enlarged view of a connectionbetween the laser probe 500 and the system 4100 and initial RFID readingto determine authenticity of the laser probe 4200. The data from theRFID tag is analyzed by the controller 4104 and a determination is madeas to whether the laser probe is authentic (i.e., suitable for use withthe laser unit). In the event that the laser probe 4200 is determined tobe authentic, the controller allows for transmission of laser radiationto the laser probe 4200. In the event that the laser probe 4200 isdetermined to not be authentic, the controller 4104 preventstransmission of laser radiation to the laser probe.

Accordingly, the authentication system of various embodiments may ensurethat only authorized laser probes are able to be used with the laserunit. The authentication ensures that only those laser probesrecommended and authorized by a manufacturer are to be used, therebyensuring that the laser system functions as intended and patient safetyis maintained. The authentication further protects against the use ofcounterfeit components. As counterfeit proprietary components becomemore prevalent, the need to authenticate original products becomesincreasingly necessary. By embedding RFID directly into the laser probeand utilizing RFID technology for authentication, manufacturers can foilcounterfeiters and secure recurring revenue streams, which may otherwisebe lost due to counterfeit products.

FIGS. 34 and 35 show further examples of how probes may be authenticatedfor use with an excimer laser unit for ELT treatments. FIG. 34 is aflowchart of an embodiment for authenticating a probe for use with anexcimer laser unit. FIG. 35 is a flowchart of an embodiment forpreventing use of an unauthenticated probe.

At 3402, a probe may be connected to an ELT machine. The probe may havean RFID tag or other readable sensor or memory. The memory may includedata that is used to authenticate the probe. At 3404, the authenticationdata stored on the probe may be read, for example, by a reader on theELT machine. At 3406, the authentication data may be determined to bevalid, for example by a processor of the ELT machine. In variousembodiments, if the ELT machine is connected to a network of othercomputing devices, a processor of another device (e.g., a remote server)may be used to determine that the authentication data is valid. Theauthentication data may be encrypted or otherwise encoded so that theauthentication data may be decoded or decrypted before determining itsvalidity. Data stored on the probe may further be indicative of otherinformation beyond its mere validity or invalidity. For example, data onthe probe may indicate a country, city, or facility of origin (e.g.,where the probe was made), a type of probe, a brand or trade name of theprobe, a type of material used in the probe, an identity of a purchaserof the probe, an identity of a manufacturer of the probe, etc. As such,the ELT machine (either using its own processor or by way of anothercomputing device) may determine various information about the probestored on the probe. In various embodiments, the probe may determine thevalidity of the probe based on a lookup table or other database of probeinformation. For example, a lookup table or database may includeinformation about valid probes, invalid probes, etc. If theauthentication data matches data stored in the lookup table or databaseassociated with valid probes, the probe may be considered valid. Thelookup table may be stored on memory of the ELT machine or on the memoryof another computing device connected to the ELT machine via a network.

If the probe is authenticated at 3406, the probe may be used for an ELTtreatment at 3408. The probe may further be used in accordance withadditional data stored on the probe or otherwise determined about theprobe based on the data stored on the probe. For example, data stored onthe probe may indicate how much total energy should be permitted to passthrough the probe without significant degradation, may indicate how manytotal shots the probe should be used for, what wavelength of energyshould be used with the probe, and/or any other aspect of using theprobe. In various embodiments, instead of storing that data on theprobe, the ELT machine or another computing device may identify theprobe as a certain type of probe based on the data stored on the probe.In such embodiments, the ELT machine or other computing device may thendetermine, based on the type of probe that is attached, the additionalinformation about how the probe should be used (e.g., how much totalenergy, number of shots, wavelength, etc.). Such information may furtherbe stored in a lookup table or database, such that authentication canhappen along with identifying other aspects of the probe even if thoseaspects are not specifically stored on the probe itself. Such lookuptables or databases may further be updated over time with informationabout new probes being manufactured so that ELT machines can properlydetermine whether probes are valid or not. Such updates may occur over anetwork, such as the internet.

At 3410, the authentication data on the probe is changed (e.g., the datastored on the memory of the probe is erased, changed, rewritten, addedto, etc.) so that the authentication data is no longer valid. In otherwords, the data on the probe may be modified in some way such that, ifthe probe is reconnected to the ELT machine or another ELT machine, theELT machine will determine that the probe is invalid and not permitusage of the probe. In this way, probes not made by a trustedmanufacturer, probes that have already been used, probes that have beentampered with, etc., cannot be used. Similarly, if an ELT machine findsno data on a probe (e.g., the probe does not have an RFID tag, memory,etc.), the ELT machine may determine that the probe is invalid andprevent use of such a probe. Such methods protect patients, ascounterfeit probes may not be manufactured properly and can lead toaccidents where patient's eyes are damaged. Similarly, probes that havealready been used may also be ineffective or dangerous for use on apatient, as the fiber optics in the probe may degrade after use.

Although embodiments described with respect to FIG. 34 relate to a probehaving a memory which may be modified by an ELT machine, otherembodiments of validating a probe are further contemplated herein. Forexample, the memory of a probe or RFID tag may have a static code ordata stored thereon. The ELT machine may read that data from a probe,and check a database or lookup table to determine if that particularprobe has been used before, and/or determine if the data on the probe isvalid. If the data is valid but the lookup table or database does notindicate that the probe has been used before, the probe may be used withthe ELT machine. Once the probe is used, a processor of the ELT machineor another computing device may update the lookup table or database toindicate that the particular probe associated with the data read fromthe probe has been used. Then if the ELT machine or other ELT machinesread the data from that probe again, it can be determined from thelookup table or database that the probe has already been used, and theprobe will not be permitted for use with the ELT machine.

FIG. 35 describes a method 3500 where probes are determined to beinvalid. At 3502, it is determined that an invalid probe is connected tothe ELT machine (e.g., based on data stored on the probe). At 3504, theELT machine or a computing device associated with the ELT machinedisplays on an interface that the probe is invalid. As such, the probemay not be used with the ELT machine. In various embodiments, the method3500 may end after 3504.

In other embodiments, at 3506, it may be determined that a predeterminedthreshold number of invalid probes have been attempted to be used withthe ELT machine. In other words, if a particular number of invalidprobes' use has been attempted, the machine may determine that aparticular threshold has been met or exceeded. The threshold may be setby the manufacturer of the ELT machine, for example. After determiningthat the threshold has been exceed, the interface may display at 3508that the ELT machine is disabled, not operating, or otherwise out ofcommission. Optionally, other information may be displayed, such asinstructing an operator to get the ELT machine services, instructing theoperator that the machine must be reset by a representative of themanufacturer due to too many invalid probe uses, etc. In variousembodiments, such as when an ELT machine is connected to network, analert or message may also be transmitted to a computing devicecontrolled by or associated with a manufacturer of the ELT machine orother party than the operator of the ELT machine, so that themanufacturer or other party may be alerted to an attempted use of aninvalid probe. An alert or message may similarly be sent only if apredetermined threshold of invalid probes are attempted to be used,which may be the same or a different threshold than the threshold thattriggers disabling of the ELT machine. At 3510, the ELT machine itselfmay be disabled based on the threshold being met or exceeded. In thisway, patients may be protected against operators that repeatedly attemptto use invalid probes for eye procedures.

As used in any embodiment herein, the term “module” may refer tosoftware, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices. “Circuitry”, as usedin any embodiment herein, may comprise, for example, singly or in anycombination, hardwired circuitry, programmable circuitry such ascomputer processors comprising one or more individual instructionprocessing cores, state machine circuitry, and/or firmware that storesinstructions executed by programmable circuitry. The modules may,collectively or individually, be embodied as circuitry that forms partof a larger system, for example, an integrated circuit (IC), systemon-chip (SoC), desktop computers, laptop computers, tablet computers,servers, smart phones, etc.

Any of the operations described herein may be implemented in a systemthat includes one or more storage mediums having stored thereon,individually or in combination, instructions that when executed by oneor more processors perform the methods. Here, the processor may include,for example, a server CPU, a mobile device CPU, and/or otherprogrammable circuitry.

Also, it is intended that operations described herein may be distributedacross a plurality of physical devices, such as processing structures atmore than one different physical location. The storage medium mayinclude any type of tangible medium, for example, any type of diskincluding hard disks, floppy disks, optical disks, compact diskread-only memories (CD-ROMs), compact disk rewritables (CD-RWs), andmagneto-optical disks, semiconductor devices such as read-only memories(ROMs), random access memories (RAMs) such as dynamic and static RAMs,erasable programmable read-only memories (EPROMs), electrically erasableprogrammable read-only memories (EEPROMs), flash memories, Solid StateDisks (SSDs), magnetic or optical cards, or any type of media suitablefor storing electronic instructions. Other embodiments may beimplemented as software modules executed by a programmable controldevice. The storage medium may be non-transitory.

As described herein, various embodiments may be implemented usinghardware elements, software elements, or any combination thereof.Examples of hardware elements may include processors, microprocessors,circuits, circuit elements (e.g., transistors, resistors, capacitors,inductors, and so forth), integrated circuits, application specificintegrated circuits (ASIC), programmable logic devices (PLD), digitalsignal processors (DSP), field programmable gate array (FPGA), logicgates, registers, semiconductor device, chips, microchips, chip sets,and so forth.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The term “non-transitory” is to be understood to remove only propagatingtransitory signals per se from the claim scope and does not relinquishrights to all standard computer-readable media that are not onlypropagating transitory signals per se. Stated another way, the meaningof the term “non-transitory computer-readable medium” and“non-transitory computer-readable storage medium” should be construed toexclude only those types of transitory computer-readable media whichwere found in In Re Nuijten to fall outside the scope of patentablesubject matter under 35 U.S.C. § 101.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

Calibration System for Improving Manufacture Tolerance in Excimer LaserOptical Fibers

In the medical industry, there are many surgical devices, instruments,and systems comprised of individual components that must work togetherproperly to ensure treatment is performed safely and effectively. It iscritical that any given component falls within an acceptable toleranceto ensure that the component physically fits and interacts appropriatelywith other components and functions as intended.

The actual production of any product (or operation of any system)involves some inherent variation of input and output. Measurement errorand statistical uncertainty are also present in all measurements.Accordingly, tolerance is an inherent aspect when designing a device,instrument, or system. The concept of tolerance, sometimes referred toas engineering tolerance, relates to the permissible limit or limits ofvariation in a physical dimension of the component, a measured value orphysical property of the component, spacing between the component andanother component, and the like. Accordingly, if a component fallsoutside of a permissible tolerance (i.e., the component is too small,too large, fails to have acceptable properties, etc.), then the overalldevice, instrument, or system will fail to perform as designed.

One example of a surgical system composed of multiple components is amedical laser system. The medical laser system generally consists of alaser unit and a separate laser probe having an optical fiber fordirecting laser radiation from the laser unit to a treatment area. Laserunits provide laser light at specific wavelengths and, as a result, maybe designed to perform specific procedures. For example, certainprocedures may require photocoagulation of a target tissue, which occursupon delivery of laser radiation at a first wavelength, while otherprocedures may require photoablation of a target tissue, which occursupon delivery of laser radiation at a second wavelength. In turn,optical fibers to be used with these laser systems may have specificdimensions, material compositions, and/or functional properties (i.e.,operation at specific temperatures and wavelengths) so as to function asintended with the corresponding laser unit.

While current laser units allow for some tolerance (i.e., optical fiberdimensions, properties, or conditions may have some variation withoutsignificantly affecting functioning of the laser system), the range ofpermissible tolerance is exceedingly tight. For example, optical fibershave a very small diameter which is generally measured on the micronscale. The diameter of the optical fiber may impact the transmission oflaser radiation through the optical fiber and thus may impact the laserradiation emitted from the delivery tip of the optical fiber. As such,there is very little room for variation in the manufacture of opticalfibers. Manufacturing costs are increases as a result of the high degreeof precision required to make sure the diameter of an optical fiberfalls within the permissible tolerance. Furthermore, if a given opticalfiber falls outside of a permissible tolerance (i.e., the diameter istoo be or too small), use of the noncompliant optical fiber may resultin transmission of laser radiation that is not at the desiredwavelength. In turn, use of a noncompliant optical fiber runs the riskof providing an ineffective treatment and, in some instance, can causeadditional unintended damage and harm.

Various embodiments provide a system for calibrating output from a lasersource to compensate for increased variation in laser optical fibers. Insuch a system, the elements generally include a laser source forgenerating laser energy to be provided to one of a plurality of laserprobes couplable thereto. Each laser probe includes an optical fiber,including a fiber optic core, adapted to direct laser radiation from thelaser source, through the fiber, and to a desired the treatment area.The system further includes a laser management system for managing thelaser source. The management system includes a control system configuredto adjust laser energy output from the laser source to any given laserprobe to maintain a consistent level of laser radiation delivered to thetarget area, despite variation in the fiber optic core of any givenlaser probe.

More specifically, as part of the initial setup, the control systemreceives data associated with a laser probe coupled to the laser source.The data may include one or more dimensions of the fiber optic core ofthe laser probe, including fiber optic core diameter. The data is thenanalyzed by the controller and, based on the analysis, a determinationof an optimum level of laser energy output from the laser source ismade. The optimum level of laser energy output from the laser source isbased on a correlation of the laser probe data, such as specificdimensions of the fiber optic core, with calibration data. Thecalibration data may generally include a plurality of sets of values,wherein each set of values may include a laser energy output level fromthe laser source, a diameter of a fiber optic core of a laser probe toreceive the laser energy output level, and the resulting wavelengthvalue of laser radiation emitted from the delivery tip of the laserprobe. The resulting wavelength value of laser radiation to be emittedfrom the delivery tip may remain constant, regardless of the diameter ofthe fiber optic core. In such an embodiment, the laser management system(i.e., the control system) automatically adjusts the laser energy outputlevel from the laser source (i.e., increases or decreases output level)for any given diameter of a fiber optic core so as to maintain theemission of laser radiation upon a target area at a consistentwavelength, despite variation in the diameter of fiber optic cores fromthe plurality of laser probes.

Accordingly, the system of various embodiments may be able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

The various embodiments provide a system for calibrating output from alaser source to compensate for increased variation in laser opticalfibers. In such a system, the elements generally include a laser sourcefor generating laser energy to be provided to one of a plurality oflaser probes couplable thereto. Each laser probe includes an opticalfiber, including a fiber optic core, adapted to direct laser radiationfrom the laser source, through the fiber, and to a desired the treatmentarea. The system further includes a laser management system for managingthe laser source. The management system includes a control systemconfigured to adjust laser energy output from the laser source to anygiven laser probe to maintain a consistent level of laser radiationdelivered to the target area, despite variation in the fiber optic coreof any given laser probe.

Accordingly, the system of various embodiments may be able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

The system of various embodiments may be suited for intraocularprocedures in which laser treatment of target tissues is desired. Inparticular, the laser source, laser management system, and laser probesof various embodiments may be used for treating glaucoma and useful inperforming a laser trabeculostomy. However, it should be noted that thesystem consistent with the present disclosure can be used in any lasertreatment of various conditions, including other eye conditions (i.e.,diabetic eye diseases, such as proliferative diabetic retinopathy ormacular oedema, cases of age-related macular degeneration, retinaltears, and retinopathy of prematurity, and laser-assisted in situkeratomileusis (LASIK) to correct refractive errors, such asshort-sightedness (myopia) or astigmatism) as well as other conditionsin general and other practice areas (non-ocular practice areas).

FIG. 36 diagrams an excimer laser system, including a laser unit system5100 and a laser probe 5200 to be attached to the laser unit system5100. The system 5100 includes a laser source 5102, and a lasermanagement system 5108. The laser probe 5200 includes a fiber core 5204.As will be described in greater detail herein, many of the components ofthe laser unit system 5100 may be contained in a housing, such as amoveable platform, to be provided in a setting in which the procedure isto be performed (e.g., operating room, procedure room, outpatient officesetting, etc.) and the probe 5200 may connect to the housing for useduring treatment. Upon coupling the probe 5200 to the housing, the fibercore 5202 is coupled to the laser source 5102 and adapted to directlaser radiation from the laser source 5102, through the fiber, and tothe treatment area.

The laser source 5102 includes an excimer laser 5104 and a gas cartridge5106 for providing the appropriate gas combination to the laser 5104.The excimer laser 5104 is a form of ultraviolet laser that generallyoperates in the UV spectral region and generates nanosecond pulses. Theexcimer gain medium (i.e., the medium contained within the gas cartridge5106) is generally a gas mixture containing a noble gas (e.g., argon,krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine).Under the appropriate conditions of electrical stimulation and highpressure, a pseudo-molecule called an excimer (or in the case of noblegas halides, exciplex) is created, which can only exist in an energizedstate and can give rise to laser light in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 5104of the present system 5100 is an XeCl excimer laser and emits awavelength of 308 nm.

The laser management system 5108 manages the laser source 5102. Inparticular, as shown in FIG. 37 , the laser management system 5108includes a controller 5110 (also referred to herein as a “control system5110”). The controller 5110 provides an operator (i.e., surgeon or othermedical professional) with control over the output of laser signals(from the laser source 5102 to the fiber core 5202) and, in turn,control over the transmission of laser energy from the fiber core 5202of the probe 5200. However, prior to providing an operator with controlover laser output, the laser management system 5108 provides acalibration process in which laser energy output from the laser source5102 to the laser probe 5200 is calibrated to maintain a consistentlevel of laser radiation delivered from the probe 5200 to the targetarea, despite any variation in the fiber optic core 5202 of the probe5200.

FIG. 37 diagrams the laser unit system 5100 and calibration of laseroutput to a laser probe 5200 to be used with the system 5100 to accountfor variation in the fiber optic core of the laser probe 5200. FIG. 38diagrams a process of calibrating laser output, including adjustment oflaser energy output from the laser source to a laser probe to accountfor variation in the fiber optic core 5202 of the laser probe 5200.

As part of the initial setup, the controller 5110 receives dataassociated with a laser probe coupled to the laser source 5102. In thisinstance, data from laser probe 200 is provided to the controller 5110.This data may be manually entered (via a user interface provided on thesystem 5100) or may be automatically read from readable device or labelon the probe 200 via an associated reader of the system 5100. The datamay include physical characteristics of the probe 5200, including, butnot limited to, physical dimensions of the fiber optic core 5202, one ormore measured values or physical properties of the fiber optic core5202, and physical dimensions and/or measured values or physicalproperties of other components of the probe 5200. In one embodiment, thedata includes a diameter of the fiber optic core 5202.

The data is then analyzed by the controller 5110 and, based on theanalysis, a determination of an optimum level of laser energy outputfrom the laser source 5102 is made. The analysis is based on acorrelation of the laser probe data, such as specific dimensions of thefiber optic core, with calibration data. The calibration data is storedin a database, either a local database (i.e., calibration database 5112)forming part of the laser unit system 5100, or a remote database hostedvia a remote server 5300 (i.e., calibration database 5302). For example,in some embodiments, the system 5100 may communicate and exchange datawith a remote server 5300 over a network. The network may represent, forexample, a private or non-private local area network (LAN), personalarea network (PAN), storage area network (SAN), backbone network, globalarea network (GAN), wide area network (WAN), or collection of any suchcomputer networks such as an intranet, extranet or the Internet (i.e., aglobal system of interconnected network upon which various applicationsor service run including, for example, the World Wide Web).

The calibration data may generally include a plurality of sets ofvalues, wherein each set of values may include a laser energy outputlevel from the laser source, a diameter of a fiber optic core of a laserprobe to receive the laser energy output level, and the resultingwavelength value of laser radiation emitted from the delivery tip of thelaser probe. The resulting wavelength value of laser radiation emittedfrom the delivery tip may remain constant, regardless of the diameter ofthe fiber optic core. In such an embodiment, the laser management system(i.e., the control system) automatically adjusts the laser energy outputlevel from the laser source (i.e., increases or decreases output level)for any given diameter of a fiber optic core so as to maintain theemission of laser radiation upon a target area at a consistentwavelength, despite variation in the diameter of fiber optic cores fromthe plurality of laser probes.

The controller 5110 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 5104 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the laser system 5100 as described herein, including thecalibration process. For example, the controller 5110 may includecustom, proprietary, known and/or after-developed statistical analysiscode (or instruction sets), hardware, and/or firmware that are generallywell-defined and operable to receive two or more sets of data andidentify, at least to a certain extent, a level of correlation andthereby associate the sets of data with one another based on the levelof correlation.

The excimer laser unit 100 of FIG. 4 may be similar to, may be used as(in whole or in part) as the laser unit system 5100 and/or the lasersource 5102. In various embodiments, the laser source 5102 (includingthe excimer laser 5104 and gas cartridge 5106) and laser managementsystem 5108, including the controller 5110, may be contained within thehousing 402. An operator may manually input the laser probe data via theinteractive user interface to thereby provide such data to the lasermanagement system 5108 and controller 5110. However, in variousembodiments, the data may be automatically read from a readable deviceor code (e.g., optically and/or electronically readable) and/or a labelon the probe 5200 via an associated reader of the system 5100.

A probe, such as those shown in FIGS. 4-6, 21, 24, 29 , and/or 32 may beused with the excimer laser system 5100. For example, FIG. 39 shows anembodiment of a laser probe 500 attached to a laser unit system 5100. Aspreviously described, upon attachment of the laser probe 500 to thesystem 5100 (i.e., coupling between the connection assembly 504 of theprobe 500 and connection port 406 of the system 400), the lasermanagement system 5108 (including the controller 5110) performcalibration processes prior to use of the probe 500. In particular, dataassociated with characteristics of the probe 500, such as the diameterof the fiber optic core, is provided to the laser management system5108. The data is then analyzed by the controller 5110 and, based on theanalysis, a determination of an optimum level of laser energy outputfrom the laser source is made. The optimum level of laser energy outputfrom the laser source may be based on a correlation of the laser probedata, such as specific dimensions of the fiber optic core, withcalibration data. The controller 5110 automatically adjusts the laserenergy output level from the laser source (i.e., increases or decreasesoutput level) for any given diameter of a fiber optic core so as tomaintain the emission of laser radiation upon a target area at aconsistent wavelength, despite variation in the diameter of fiber opticcores from the plurality of laser probes.

Accordingly, the system of the various embodiments is able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

Combination Treatment Using ELT

In glaucoma, there is a build-up of fluid known as aqueous humor in theanterior chamber of the eye. The fluid normally drains from the eye inan area known as the trabecular meshwork, typically flowing throughSchlemm's canal in the trabecular meshwork. However, when an individualsuffers from glaucoma, the fluid build-up causes elevated intraocularpressure (TOP). The increased pressure gradually leads to damage of theoptic nerve and causes irreversible vision loss.

Traditional methods of treating glaucoma manage the condition bydecreasing the IOP or producing less aqueous humor. Traditional glaucomatreatment includes pharmaceutical treatments, laser treatments, surgicaltreatments, and combinations thereof. Pharmaceutical treatments do notprovide a permanent solution and instead manage the condition bydecreasing production of the fluid or increasing drainage of the fluidto lower IOP. Laser treatments are also used to reduce the IOP byincreasing fluid outflow or decreasing fluid production. However, laserand pharmaceutical treatments often are not effective in treatingadvanced stages of glaucoma. Thus, individuals suffering from glaucomaare also treated by surgical procedures, such as inserting an implantinto the eye to increase drainage. However, these procedures areaccompanied by risks, such as dislodgment of the implant.

The various embodiments provide methods for combined treatment ofglaucoma using excimer laser trabeculostomy (ELT). Methods includeperforming ELT on a subject having glaucoma who has previously undergonea failed treatment. Because glaucoma is a progressive disease, previoustreatments may be rendered ineffective as the condition worsens.Therefore, glaucoma patients often endure several failed treatments.Methods of the various embodiments provide treatment of glaucoma usingELT and can be implemented even when previous treatment methods havefailed. During the ELT procedure, a laser probe is positioned proximateto the Schlemm's canal to create perforations the trabecular meshworkand/or Schlemm's canal to immediately improve fluid drainage. Theperforations can also increase outflow of aqueous humor and reducepressure in the eye.

In various examples, the failed treatment is a traditional method oftreating glaucoma, such as a prescribed medication or pharmaceuticaltreatment, laser treatment, surgical treatment, or combinations thereof.Typically, a prescribed medication or pharmaceutical treatment is amedicated eye drop, such as alpha agonists, beta blockers, carbonicanhydrase inhibitors, cholinergic agonists, prostaglandin/prostamideanalogues, or combinations thereof. Examples of laser treatments includetrabeculoplasty, iridotomy, iridectomy, and combinations thereof.Examples of trabeculoplasty include argon laser trabeculoplasty (ALT)and selective laser trabeculoplasty (SLT). Surgery is a traditionally aprocedure of last resort after medical and laser therapies, due torelatively high complication rates and unpredictability of proceduressuch as trabeculectomies. Examples of surgical treatment includeinsertion of a shunt or implant, trabeculectomy, trabeculotomy,goniotomy, deep sclerectomy, viscocanalostomy, or combinations thereof.

An example is directed to providing glaucoma treatment to a subject whohas been administered previous glaucoma treatments that have failed orhave been rendered ineffective. For example, a pharmaceutical treatmentmay have been previously effective in treating the subject's glaucomabefore the disease progressed to a state where the pharmaceuticaltreatment was rendered ineffective. The subject may have undergone alaser treatment, such as selective laser trabeculoplasty (SLT), fortreatment of the glaucoma. SLT may have been effective in treating theglaucoma until the condition worsened. Various methods provide ELT as atreatment after the previously-administered treatments have failed orhave been rendered ineffective, allowing for drainage of the fluidbuild-up in the anterior chamber. This includes a re-administration ofELT in the same or another part of the eye (quadrant).

In an example, a subject with advanced glaucoma was administered aprescription medication until the prescription was ineffective, SLT as alaser therapy until the SLT was ineffective, and implant of a stent,which has since become dislodged. Because the subject has advancedglaucoma, treatment methods such as pharmaceutical or existing lasertherapy may not be effective in treating the condition. Moreover,because the surgical treatment resulted in a failed stent placement, thestent is not draining the build-up of aqueous humor in the anteriorchamber of the eye. By providing ELT treatment according to variousmethods, perforations are created in the trabecular meshwork and/orSchlemm's canal, and the aqueous humor is allowed to drain. Thus,various embodiments are effective in draining the fluid build-up, evenwhen previous treatments have failed.

In some embodiments, one or more previous treatments remain effective.In such instances, ELT is administered to provide combination treatmentof glaucoma. Providing ELT in addition to other effective treatmentscreates increased drainage of the aqueous humor from the anteriorchamber of the eye. For example, a subject having glaucoma that hasundergone one failed treatment method, such as a pharmaceuticaltreatment, may be administered ELT and SLT as combination therapy. Insome instances, such a combined treatment may be administered to thepatient during the same surgical visit.

During the ELT procedure, a physician guides a delivery tip of a fiberprobe through a corneal incision in the eye and towards the trabecularmeshwork. In some examples, various embodiments further compriseadministering anesthesia to the subject before making the incision andinserting the probe. Typically, the incision has a length of about ⅛inch or smaller. In some examples, one or more sutures are used to closethe incision after ELT treatment. The delivery tip is guided by thephysician to a position proximate to the Schlemm's canal to createpermanent perforations the trabecular meshwork and/or Schlemm's canal.Fluid drainage in the anterior chamber of the eye is immediatelyimproved by the perforations created in Schlemm's canal and/or themeshwork by the excimer laser. The perforations can also increaseoutflow of aqueous humor and reduce pressure in the eye. In some cases,the physician uses a Gonio lens, endoscope, or other illumination sourceto aid in positioning the delivery tip of the fiber probe. Typically, aphysician will use a gonio lens to intraoperatively observe a slightreflux hemorrhage as a quality criterion, thereby allowing effectivepositioning of the fiber at the trabecular meshwork to create apassageway into Schlemm's canal. A further quality criterion is minorreflux bleeding that can be observed intraoperatively, thus allowingeffective positioning of the fiber at the trabecular meshwork to openSchlemm's canal.

Once the delivery tip is at a position proximate to the Schlemm's canal,a series of shots of laser energy are delivered to the trabecularmeshwork. In an example, a 308-nm xenon-chloride ultraviolet excimerlaser is used in various embodiments. The 308-nm xenon-chlorideultraviolet excimer laser causes minimal thermal damage compared withvisible or infrared lasers. In some examples, the excimer laser is anencapsulated xenon chloride (XeCl) excimer laser such as the EXTRA LASERmanufactured by MLase AG. Unlike argon and selective lasertrabeculoplasty, ELT precisely excises tissue without causing thermalinjury or scarring the surrounding tissue. Because ELT is a non-thermalprocedure, tissue reactions in the trabecular meshwork are not shown oractivated post-operatively. The lack of heat generation in ELT allowsfor a nearly absent activation of postoperative tissue reactions andprovides long-term stability of the pressure-reducing effects.

Moreover, to avoid the corneal absorption of laser radiation, an opticalfiber is used to deliver the energy. The delivery tip of the fiber probecomprises the optical fiber jacketed in metal, such as stainless steel.In some examples, the delivery tip is beveled (e.g., at 0°, 15°, 30°,and 45° with respect to the tip). The fiber probe comprises an opticalfiber suitable for UV light that is embedded into a handheld laserapplicator. For example, a FIDO LASER APPLICATOR manufactured by MLaseAG may be used as the fiber probe.

To achieve easier drainage of the aqueous humor, which leads to reducedIOP, a total of about 10 ELT sites or perforations, each with about a200 μm diameter, are lasered into the trabecular meshwork and/orSchlemm's canal. In an example, about 10 shots from excimer laser sourceare applied to each eye. In some examples, greater than about 10 shotsare applied to each eye. In comparison, stents and implants have smallerindividual diameters that are between about 80 μm to about 120 μm.

In some embodiments, the patient is administered an anesthetic beforesurgery. In some examples, the anesthesia is topical. In some examples,the anesthesia comprises anesthetic drops. In some instances, generalanesthesia is administered to the patient. The eye is anesthetized firstwith eye drops and then an injection of anesthetic is administeredaround the eye. The anesthetic injection itself may cause some milddiscomfort; a slight sensation of pressure as the anesthetic isdelivered. The injection anesthetizes the eye, preventing not only painbut also excessive eye movement during surgery.

Various embodiments provide treatment of glaucoma using ELT afterpreviously-administered treatments have failed or been renderedineffective. Previous treatment methods include pharmaceuticaltreatments, laser treatments, surgical treatments, or combinationsthereof. For example, a patient may have previously been prescribedmedicated eye drops and may have undergone a selective lasertrabeculoplasty (SLT) procedure, but the patient's condition hasprogressed to a point where those treatments are no longer effective.The various embodiments provide methods of treating the patient byadministering ELT treatment to the glaucoma patient who has previouslyundergone failed treatments.

In various embodiments, the failed treatment is a prescribed medicationor pharmaceutical treatment, laser treatment, surgical treatment, orcombination thereof. Traditional methods for treating glaucoma includemedicated drops, laser treatment, and surgical treatment. Surgery is atraditionally a procedure of last resort after medical and lasertherapies, due to relatively high complication rates andunpredictability of procedures such as trabeculectomies.

Typically, a prescribed medication or pharmaceutical treatment is amedicated eye drop, such as alpha agonists, beta blockers, carbonicanhydrase inhibitors, cholinergic agonists, prostaglandin/prostamideanalogues, or combinations thereof. Examples of laser treatments includetrabeculoplasty, iridotomy, iridectomy, and combinations thereof.Examples of trabeculoplasty include argon laser trabeculoplasty (ALT)and selective laser trabeculoplasty (SLT). Examples of surgicaltreatment include insertion of a shunt or implant, trabeculectomy,trabeculotomy, goniotomy, deep sclerectomy, viscocanalostomy, orcombinations thereof.

Medication is the most common early treatment for glaucoma, andpharmaceutical options include medicated eye drops, pills, or both. Allmedications available for the treatment of glaucoma must be takenregularly. Examples of the medicated eye drops include alpha agonists,beta blockers, carbonic anhydrase inhibitors, cholinergic agonists, andprostaglandin/prostamide analogues.

Alpha agonists, such as apraclondine and brimonidine, are used to reducethe production of fluid in the eye and to improve the flow of fluid outof the eye. The drops are typically used two or three times a day.Apraclonidine is for short-term use following laser treatment or todelay laser treatment. Brimonidine is licensed for the long-termtreatment of glaucoma, but is contra-indicated for children under theage of two years. Side effects include a dry mouth, tiredness, andgeneral weakness. Patients may develop a severe allergic reaction to thedrops, causing the eye to become increasingly red, sore, and sticky.Alpha agonists include formulations of brimonidine (ALPHAGANmanufactured by Allergan, Inc.).

Beta blockers include betaxolol, carteolol, levobunolol, and timolol,and are used to reduce the production of fluid in the eye. The drops areused once or twice a day and are not typically prescribed for anyonesusceptible to chest or breathing problems. Side-effects include slowpulse, dizziness, asthma, tiredness, depression, loss of libido, andimpotence. Beta adrenergic blocking drops include timolol (TIMOPTICmanufactured by Bausch and Lomb and BETIMOL manufactured by Akorn,Inc.), levobunolol (BETAGAN manufactured by Allergan, Inc.), betaxolol(BETOPTIC manufactured by Alcon Laboratories Inc.), carteolol (OCUPRESSmanufactured by Bausch and Lomb Pharmaceuticals Inc.), and metipranolol(OPTIPRANOLOL manufactured by Bausch & Lomb Pharmaceuticals, Inc.).

Carbonic anhydrase inhibitors, such as brinzolamide and dorzolamide,reduce production of fluid in the eye. The drops are used two or threetimes a day on their own, or twice a day if with another drop.Side-effects include redness of the eye, crusty eyelashes, fatigue, anda bitter taste in the mouth. The carbonic anhydrase inhibitors includeoral agents acetazolamide (DIAMOX SEQUELS manufactured by TevaPharmaceuticals USA, Inc.) and methazolamide (NEPTAZANE manufactured byPerrigo Company plc, Dublin Ireland) and the eyedrops brinzolamide(AZOPT manufactured by Alcon Laboratories Inc., a Novartis company,Novartis Pharmaceuticals Corporation, USA) and dorzolamide (TRUSOPTmanufactured by Santen Pharmaceutical Co., Ltd.).

Cholinergic agonist drops, such as pilocarpine, are used to improve theflow of fluid out of the eye. When using cholinergic agonist drops, theusual fluid flow route is improved. Drops are used three or four times aday. Miotic drops include pilocarpine hydrochloride solutionmanufactured by Akorn, Inc.

Prostaglandin/prostamide analogues include bimatoprost, latanoprost,tafluprost, and travoprost. The drops are used to improve the fluid flowout of the eye through a different way from the usual one. The drops areused once a day. Side effects include a pink eye that typically improvesover a period of time, an iris that darkens in color, longer and darkereyelashes, and darkened skin around the orbit of the eye. Examples ofprostanoid FP-receptor (sensitive to prostaglandin F) agonists includelatanoprost (XALATAN manufactured by Pfizer Inc.), bimatoprost (LUMIGANmanufactured by Allergan, Inc.), travoprost (TRAVATAN Z manufactured byNovartis Pharmaceuticals Corporation), unoprostone (RESCULA manufacturedby Sucampo Pharma Americas, LLC), and tafluprost (ZIOPTAN manufacturedby Akorn, Incorporated).

Several laser treatments are used in the treatment of glaucoma.Different laser treatments are used to treat a number of different typesof glaucoma. In open angle glaucoma, laser treatment is used to reducethe intraocular pressure (TOP) by increasing outflow of aqueous fluidfrom the eye (laser trabeculoplasty) or to decrease the formation ofaqueous fluid (cyclophotocoagulation). In narrow angle glaucoma, laseriridotomy is used to make a small hole in the iris to improve fluidoutflow or iridoplasty is performed to tighten the iris and open thedrainage angle.

Argon laser trabeculoplasty (ALT) is used to treat chronic open angleglaucoma. ALT was first performed with an argon laser, although lasersused today are frequency doubled YAG lasers that perform a similarfunction. Typically, the trabecular meshwork is targeted, treating halfof the eye in a single session. If necessary, the other half is treatedlater. The treatment requires eye drop anesthesia. Treatment may be usedin place of eye drops, but typically is used as an adjunct to continuingtreatment with drops. A different type of laser therapy or surgery maybe required, as the effect of ALT may wear off after a few years.Several follow-up appointments are required after treatment in order tomonitor TOP and inflammation in the patient. Typically, most patientsrequire anti-glaucoma drops in the long-term to control the TOP at thedesired level.

Selective laser trabeculopalsty (SLT) is used to treat chronic openangle glaucoma. SLT is similar to ALT, but uses a gentler laser beam oflarger size. In SLT, a laser is directed at the trabecular meshwork, butuses a laser with a lower power than ALT treatment. The best SLT resultsare produced when all 360 degrees of the trabecular meshwork is treatedat once. Unlike ALT, SLT can be repeated if the effect wears off.Several follow-up appointments are required after treatment in order tomonitor TOP and inflammation in the patient. Typically, most patientsrequire anti-glaucoma drops in the long-term to control the TOP at thedesired level.

Trans-scleral photocoagulation, cyclodiode or diode laser cycloablation,is used to treat chronic open angle glaucoma. A laser is used to targetthe ciliary body that produces the fluid. A general anesthetic or alocal anesthetic injection is often required for treatment.Trans-scleral photocoagulation can be repeated if the TOP is notconsidered low enough or the effect wears off with time. Cyclodiode isalso recommended in a number of other forms of glaucoma where very highIOPs occur and traditional surgery is contraindicated or impossible.Patients undergoing cyclodiode often require strong painkillers afterthe treatment. Several follow-up appointments are required aftertreatment in order to monitor TOP and inflammation in the patient.Typically, most patients require anti-glaucoma drops in the long-term tocontrol the TOP at the desired level.

Laser iridotomy is used to treat closed and narrow angle glaucoma. Inlaser iridotomy, a small hole is made with a Yag laser in order torelieve a narrow or closed angle. The fluid passes through the hole,inducing the iris to fall back away from the drainage meshwork, and thefluid drains freely through the meshwork. Numbing eye drops aretypically administered as an anesthetic. However, in some eyes the irisdoes not fall back as desired, thus requiring other treatments. Evenwith a good iris position, medication or surgery may still be requiredto control the TOP. Post-laser drops are required, usually in the formof steroids, and anti-glaucoma drops may be necessary temporarily orindefinitely.

Peripheral iridoplasty is used to treat closed and narrow angleglaucoma. Peripheral iridoplasty may be used when the iris has notfallen back in an eye that has undergone a laser iridotomy. An argon orfrequency doubled Yag laser is applied to the outer margins of the iristo shrink the iris away from the drainage meshwork and open the drainageangle. Anesthesia other than numbing drops may be required. Post-laserdrops are required, usually in the form of steroids, and anti-glaucomadrops may be necessary temporarily or indefinitely.

Several surgical treatments are available to treat glaucoma. However,surgical options are often a last resort and are reserved for late-stageglaucoma patients, after pharmaceutical and laser treatment options haveproved ineffective in treating the condition.

Aqueous shunts are used to reduce the intraocular pressure (TOP) inglaucoma by draining the fluid from inside the eye to a small blister orbleb behind the eyelid. Aqueous shunts have various other names such astube implants, glaucoma tube shunts, glaucoma drainage devices, andglaucoma drainage implants. Two types of shunts commonly used includethe Ahmed Glaucoma Valve (manufactured by New World Medical, RanchoCucamonga, CA, USA) and the Baerveldt Glaucoma Implant (manufactured byAdvanced Medical Optics, Inc., Santa Ana, CA, USA). The shunts are madeof a small silicone tube (less than 1 mm in diameter) attached to aplate. The tube takes the aqueous humor from inside the eye and drainsit to the plate which sits on the white of the eye (sclera). The platesits under the skin of the eye conjunctiva), behind the eyelid.

Trabeculectomy is a surgical procedure used to treat glaucoma and issometimes referred to as filtration surgery. During a trabeculectomy, aphysician removes a piece of tissue in the drainage angle of the eye tocreate an opening. The opening is partially covered with a flap oftissue from the sclera, the white part of the eye, and the conjunctiva,the clear thin covering over the sclera. The newly-created openingallows fluid to drain out of the eye, bypassing the clogged drainagechannels of the trabecular meshwork. A bleb is formed when fluid flowsthrough the new drainage opening and the tissue over the opening risesto form a little blister or bubble.

Trabeculotomy is a surgical procedure much like trabeculectomy. Aphysician removes a piece of tissue in the eye's drainage angle tocreate an opening. The newly-created opening allows fluid to drain outof the eye. Trabeculotomy surgery is for children only.

During a goniotomy, a physician uses a goniolens to see the structuresof the front part of the eye, or anterior chamber. The physician makesan opening in the trabecular meshwork, the group of tiny canals locatedin the drainage angle where fluid leaves the eye. The newly-createdopening allows fluid to flow out of the eye. Goniotomy surgery is forchildren only.

Deep sclerectomy is a non-penetrating surgical procedure used fortreatment of open angle glaucoma. The deep sclerectomy procedureinvolves removing the inner wall of Schlemm's canal andjuxta-canalicular trabecular meshwork, the structures responsible formost of the outflow resistance in open angle glaucoma. The aqueousoutflow is enhanced, and a trabeculo-Descemet's membrane (TDM) is leftintact to control aqueous outflow through the filtration site.

In viscocanalostomy, tissue flaps are cut in the conjunctiva and thesclera to expose a portion of the drainage canal (Schlemm's canal). Theprocedure involves production of superficial and deep scleral flaps,excision of the deep scleral flap to create a scleral reservoir, andunroofing of Schlemm's canal. A high-viscosity elastic gel is injectedin Schlemm's canal to open and enlarge the canal to allow increasedfluid flow out of the anterior chamber. For example, the high-viscosityviscoelastic may comprise sodium hyaluronate. The tissue flaps are thenclosed. For example, the superficial scleral flap may be sutured watertight, trapping the viscoelastic until healing takes place.

Previously-attempted treatment methods have proved ineffective attreating glaucoma in a patient. Embodiments herein use an excimer laserto permanently perforate the Schlemm's canal and/or trabecular meshworkto create an internal outflow channel. Such ablation with excimer laserscauses almost no thermal damage, thereby minimizing inflammation andformation of scar tissue. In contrast, because of inflammatory andhealing responses, other lasers, such as ruby and argon lasers, cannotachieve a permanent perforation of the trabecular meshwork. Therefore,various embodiments use ELT to reestablish outflow of fluid from the eyewithout inciting a healing response at the target tissue. Due to thelack of inflammation and scar tissue formation, methods of treatment ofvarious embodiments require less recovery time than traditional surgicalmethods, such as placement of implants.

In embodiments, multiple shots from an excimer laser are administered tothe patient in order to create perforations in the trabecular meshworkand/or Schlemm's canal. ELT converts trabecular meshwork tissue into gasby photoablation. By permanently perforating Schlemm's canal and/or thetrabecular meshwork, built-up fluid in the eye is immediately allowed todrain. Moreover, because the perforations allow for increased outflow ofaqueous humor and fluid drainage, subsequent vision loss from damage tothe optic nerve due to any build-up is thereby avoided.

FIG. 40 shows a flowchart of an embodiment 4100. Various embodiments aredirected to treating a patient having glaucoma with ELT. In variousembodiments, the energy shots delivered from the excimer laser are at aposition proximate to the Schlemm's canal. Various embodiments areperformed after a patient having glaucoma has been 4110 administeredprevious, ineffective treatments. Treatments other than ELT includetraditional pharmaceutical, laser, and surgical treatments. Forinstance, pharmaceutical treatment methods involve pills, eyedrops, orboth. Typically, a prescribed medication or pharmaceutical treatment isa medicated eye drop, such as alpha agonists, beta blockers, carbonicanhydrase inhibitors, cholinergic agonists, prostaglandin/prostamideanalogues, or combinations thereof. Examples of laser treatments includetrabeculoplasty, iridotomy, iridectomy, and combinations thereof.Examples of trabeculoplasty include argon laser trabeculoplasty (ALT)and selective laser trabeculoplasty (SLT). Examples of surgicaltreatment include insertion of a shunt or implant, trabeculectomy,trabeculotomy, goniotomy, deep sclerectomy, viscocanalostomy, orcombinations thereof.

In various embodiments, ELT is administered even if other treatmentshave been previously administered and are ineffective. For example, if ashunt was placed in a subject's eye and has since become dislodged,providing ELT treatment is still possible. The provided ELT treatmentwill allow drainage of the build-up of fluid in the eye by providingpermanent perforation of the Schlemm's canal and/or trabecular meshwork.

Methods of various embodiments include 4120 pre-operative analysis, suchas diagnosis of the eye condition, determination of course of actionbased on previously-failed treatment methods, inspection and/orvisualization of the anterior chamber of the eye to aid in placement ofthe laser probe, and analysis of number of laser shots needed fortreatment. In various embodiments, excimer laser trabeculostomy (ELT) isused to treat glaucoma.

The method includes 4130 administering anesthesia to the patient.Topical anesthesia is commonly employed, typically by the instillationof a local anesthetic such as tetracaine or lidocaine. Lidocaine and/ora longer-acting bupivacaine anesthetic may be injected into the areasurrounding (peribulbar block) or behind (retrobulbar block) the eyemuscle cone to more fully immobilize the extraocular muscles andminimize pain sensation. Optionally, a facial nerve block may beperformed using lidocaine and bupivacaine to reduce lid squeezing. Insome cases, such as for children, patients with traumatic eye injuries,and nervous or uncooperative patients and animals, general anesthesia isadministered with cardiovascular monitoring. To prepare the area forsurgery, proper sterile precautions must be taken, including use ofantiseptics like povidone-iodine and employment of sterile drapes,gowns, and gloves. In some cases, an eye speculum is inserted to keepthe eyelids open.

A physician 4140 makes a small incision on the eye of the patient.Before the ELT procedure is performed, a small incision is made in thecornea of the eye to allow introduction of the laser probe. Typically,the incision is about ⅛ inch or smaller. During the ELT procedure, aphysician guides the delivery tip of the fiber probe through a cornealincision in the eye and towards the trabecular meshwork. The deliverytip is guided by the physician to a position proximate to the Schlemm'scanal. A Gonio lens, endoscope, and/or illumination source may be usedby the physician to aid in positioning the delivery tip. By providing alaser probe at a position proximate to the Schlemm's canal, or crosswiseto the Schlemm's canal, the laser is delivered to a greater amount ofsurface area than if the laser was in a parallel or perpendicularposition to the Schlemm's canal, resulting in more perforation fromfewer laser shots. Thus, arrangement of the delivery tip at a positionproximate to the Schlemm's canal achieves optimal photoablation andperforation formation in the meshwork and/or Schlemm's canal fordrainage of fluid. The orientation and positioning of the delivery tipis critical when creating perforations in the tissue, as achievingplacement of perforations in the meshwork relative to Schlemm's canalprovides optimal drainage.

Once the delivery tip is at a position proximate to the Schlemm's canal,the physician 4150 applies ELT treatment to the patient by delivering aseries of shots of laser energy to the trabecular meshwork and/orSchlemm's canal. The physician applies pulsed photoablative energy tocreate ELT sites, or perforations, in the trabecular meshwork and/orSchlemm's canal. In some examples, a physician creates 10 ELT sites inan eye of the patient. In some examples, the physician creates greaterthan 10 ELT sites. A small amount of bloody reflux from Schlemm's canalconfirms each opening. The fiber probe is removed from the eye. Notably,the TOP decreases immediately after administering the ELT procedure.

After applying ELT treatment, a physician 4160 closes the incision.Typically, a physician uses sutures to close the incision. Somephysicians place a suture in the incision and other physicians reserve asuture for when there is persistent leakage.

Methods of the various embodiments include 4170 analyzing post-operativeresults and 4180 reporting results and/or scheduling a post-operativefollow-up appointment with the patient after surgery. For example, thephysician's analysis may include observing a small amount of bloodyreflux from Schlemm's canal to confirm each opening. By observing thebloody reflux and drainage of aqueous humor, the physician is able toimmediately verify the effectiveness of the laser treatment. In turn,the physician may report the results to the patient, prescribepost-operative medication, such as topical antibiotics and steroiddrops, and schedule a follow-up post-operative visit with the patient.For example, topical antibiotics and steroid drops are used by thepatient for 1 to 2 weeks post-operatively.

A system such as those shown in FIGS. 3-6, 21-33 , and/or 36-39 may beused in various embodiments. Such a system may include the componentsshown in FIG. 41 . FIG. 41 is a diagram of a system 6300 for treatingglaucoma according to the various embodiments. The treatment system 6300comprises an interactive user interface 6310 (example user interface410), a fiber probe 6320 (examples of fiber probes 102, 104, 500, 4200,5200), controller 6330, and an excimer laser trabeculostomy (ELT) system6340. The excimer laser system 6340 comprises an excimer laser 6350 andgas cartridge 6360. The excimer laser system 6340, interactive userinterface 6310, and fiber probe 6320 are communicatively coupled to thecontroller 6330. Moreover, the excimer laser system 6340 may becontained in a housing that includes an interactive user interface, anda fiber probe may connect to the housing for use during ELT treatment.

The controller 6330 has a processor. The processor generally includes achip, such as a single core or multi-core chip, to provide a centralprocessing unit (CPU), such as a chip from Intel or AMD. The controller6330 provides an operator (i.e., physician, surgeon, or other medicalprofessional) with control over the treatment system 6300, includingprogramming of the fiber probe, output of laser signals, and controlover the transmission of laser energy from the laser source 6350 to thefiber probe 6320 that delivers the laser transmission.

The controller 6330 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 6330 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the treatment system 6300 as described herein, includingcontrolling the laser delivery and using the interactive user interface6310 to program the number of laser shots deliverable by the fiber probe6320.

The laser system 6340 includes an excimer laser 6350 and a gas cartridge6360 for providing the appropriate gas combination to the laser 6350.The excimer laser 6350 is a form of ultraviolet laser that generallyoperates in the UV spectral region and generates nanosecond pulses. Theexcimer gain medium (i.e., the medium contained within the gas cartridge6360) is generally a gas mixture containing a noble gas (e.g., argon,krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine).Under the appropriate conditions of electrical stimulation and highpressure, a pseudo-molecule called an excimer (or in the case of noblegas halides, exciplex) is created, which can only exist in an energizedstate and can give rise to laser light in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 6350of the present system 6300 is an XeCl excimer laser and emits awavelength of 308 nm.

Methods of Transverse Placement in ELT

A leading cause of irreversible blindness is glaucoma. Typically, fluidflows freely through the anterior chamber of the eye and exits through adrainage system that includes the trabecular meshwork and Schlemm'scanal. When an individual suffers from glaucoma, a blockage in thetrabecular meshwork or Schlemm's canal prevents the fluid from drainingand results in increased pressure in the eye. If left untreated, theincreased pressure in the eye damages the optic nerve, leading togradual vision loss and eventual blindness.

Traditional methods of treating glaucoma include pharmaceuticaltreatments, laser treatments, surgical treatments, or combinationsthereof to lower pressure in the eye. Pharmaceutical treatments, such asmedicated drops, and laser treatments, such as selective lasertrabeculoplasty (SLT), often are not effective in treating advancedstages of glaucoma. Invasive surgical treatments, such as placement ofimplants or drainage stents, are used to treat advanced stages ofglaucoma. However, the invasive surgical treatments have drawbacks andrequire great precision to avoid dislodgement of the implant. Forexample, if a stent is not placed properly on the first attempt, thestent may be difficult to place at all.

The various embodiments provide treatment of glaucoma using excimerlaser trabeculostomy (ELT). During the ELT procedure, a laser probe ispositioned proximate to the Schlemm's canal to create perforations inthe trabecular meshwork and/or Schlemm's canal that form a line that istransverse to the Schlemm's canal. By permanently perforating Schlemm'scanal and/or the trabecular meshwork, built-up fluid in the anteriorchamber of the eye is immediately allowed to drain. Arrangement of thelaser probe at a position proximate to Schlemm's canal provides optimumresults by providing a greater amount of surface area for photoablationby the laser. By applying the laser at a position proximate to Schlemm'scanal, each laser shot provides photoablation of a greater amount ofsurface area, resulting in a greater perforation from fewer laser shots.

In open-angle glaucoma (OAG), the obstruction of fluid outflow at thetrabecular meshwork and inner wall of Schlemm's canal is the primarycause of elevated intraocular pressure (TOP). The various embodimentsuse an excimer laser to perforate the trabecular meshwork and/orSchlemm's canal to create an internal outflow channel, increasingdrainage of the fluid known as aqueous humor from the anterior chamberof the eye. The perforations also increase flow of aqueous humor andreduce pressure in the eye.

Methods of the various embodiments use ELT to reestablish outflow offluid from the anterior chamber of the eye without inciting a healingresponse at the target tissue. ELT converts trabecular meshwork tissueinto gas by photoablation. Ablation with excimer lasers causes almost nothermal damage, thereby minimizing inflammation and formation of scartissue. Unlike argon and selective laser trabeculoplasty procedures, ELTprecisely excises tissue without causing thermal injury or scarring thesurrounding tissue. Moreover, other lasers, such as ruby and argonlasers, cannot achieve a permanent perforation of the trabecularmeshwork because of inflammatory and healing responses. Due to the lackof inflammation and scar tissue formation, methods of the variousembodiments require less recovery time than traditional laser treatmentsor surgical treatments, such as placement of implants.

During the ELT procedure, a physician guides a delivery tip of a fiberprobe through a corneal incision in the eye and towards the trabecularmeshwork. In some embodiments, methods of the various embodimentscomprise administering anesthesia to the subject before making theincision and inserting the probe. Typically, the incision has a lengthof about ⅛ inch or smaller. The delivery tip is guided by the physicianto a position proximate to the Schlemm's canal. In various embodiments,the physician uses a light source such as a Gonio lens, endoscope, orother illumination source to aid in positioning the delivery tip.Furthermore, the light source aids the physician in verifying theeffectiveness of the laser treatment by visualizing drainage of theaqueous humor and bloody reflux emitted during the treatment.

Once the delivery tip is at a position proximate to the Schlemm's canal,the physician delivers a series of shots of laser energy to thetrabecular meshwork, and the perforations may form a line, curve, etc.that is transverse to Schlemm's canal (e.g., the perforations may be atdifferent heights of the Schlemm's canal to ensure a portion of thetrabecular meshwork that is adjacent to Schlemm's canal is perforated).Thus, arrangement of the delivery tip at successive positions that aretransverse to the Schlemm's canal achieves optimal photoablation andperforation formation in the meshwork and/or Schlemm's canal. Thecreation of a plurality of perforations therefore leads to a higherlikelihood of immediate drainage of aqueous humor from the anteriorchamber of the eye, and therefore a successful procedure and treatmentof glaucoma.

ELT treatment creates long-term openings that connect the anteriorchamber of the eye directly to Schlemm's canal using an excimer laser.Various embodiments use a 308-nm xenon-chloride ultraviolet excimerlaser, which causes minimal thermal damage compared with visible orinfrared lasers. In various embodiments, the excimer laser is anencapsulated xenon chloride (XeCl) excimer laser such as the EX TRALASER manufactured by MLase AG. Moreover, to avoid the cornealabsorption of laser radiation, an optical fiber is used to deliver theenergy from the excimer laser. The delivery tip of the fiber probecomprises the optical fiber jacketed in metal, such as stainless steel.In some examples, the delivery tip is beveled (e.g., at 0°, 15°, 30°,and 45° with respect to the tip). The fiber probe comprises an opticalfiber suitable for UV light that is embedded into a handheld laserapplicator. For example, a FIDO LASER APPLICATOR manufactured by MLaseAG may be used as the fiber probe.

To achieve easier drainage of the aqueous humor in order to reduce IOP,a total of about 10 ELT perforations, each having a diameter of about200 μm, are lasered into the trabecular meshwork and/or Schlemm's canal.In comparison, stents and implants have smaller individual diametersthat are between about 80 μm to about 120 μm. In some embodiments, aboutten shots from an excimer laser source are applied to each eye. Theenergy shots may be applied to one quadrant of the eye, the inferonasal,though could be applied to other quadrants. In some embodiments, greaterthan about ten shots may be applied to each eye and can be applied tothe inferonasal quadrant and/or to multiple eye quadrants. Because ELTis a non-thermal procedure, tissue reactions in the trabecular meshworkare not shown or activated post-operatively. The lack of heat generationin ELT allows for a nearly absent activation of postoperative tissuereactions and provides long-term stability of the pressure-reducingeffects. Moreover, unlike the traditional glaucoma treatment method ofshunt or stent placement, the stability of Schlemm's canal using ELTtreatment remains unchanged.

Glaucoma patients suffer from increased intraocular pressure due to ablockage of fluid outflow from the eye. The various embodiments use anexcimer laser to shoot perforations in the Schlemm's canal and/ortrabecular meshwork of the eye. ELT treats open-angle glaucoma at thesite of occurrence by increasing the permeability of the trabecularmeshwork. During ELT, the laser creates a direct connection between thefront chamber of the eye and the Schlemm's canal by using a fiber probein physical contact with the trabecular meshwork.

Methods of the various embodiments include inserting a probe into an eyeof a subject having glaucoma, adjusting placement of the probe tosuccessive positions to form a succession of perforations that aretransverse to Schlemm's canal in the eye by applying a plurality ofshots from an excimer laser source while the probe is proximate to thetrabecular meshwork and/or Schlemm's canal, thereby treating glaucoma bycreating a plurality of perforations in Schlemm's canal and/or thetrabecular meshwork. The perforations allow immediate drainage of fluidfrom the anterior chamber of the eye. The perforations also allow forincreased flow of aqueous humor in the eye and reduced intraocularpressure.

FIG. 42 shows a flowchart of an embodiment 7100 of methods of thevarious embodiments. Various embodiments are directed to treating apatient having glaucoma with ELT. In various embodiments, energy shotsfrom the excimer laser are delivered by a fiber probe at a positionsforming a transverse line or curve with respect to the Schlemm's canal.In some examples, methods include 7110 pre-operative analysis, such asdiagnosis of the eye condition and inspection and/or visualization ofthe anterior chamber of the eye to aid in placement of the laser probe.In various embodiments, excimer laser trabeculostomy (ELT) is used totreat glaucoma.

In some embodiments, the method includes 7120 administering anesthesiato the patient. Topical anesthesia is commonly employed, typically bythe instillation of a local anesthetic such as tetracaine or lidocaine.Lidocaine and/or a longer-acting bupivacaine anesthetic may be injectedinto the area surrounding (peribulbar block) or behind (retrobulbarblock) the eye muscle cone to more fully immobilize the extraocularmuscles and minimize pain sensation. Optionally, a facial nerve blockmay be performed using lidocaine and bupivacaine to reduce lidsqueezing. In some cases, such as for children, patients with traumaticeye injuries, and nervous or uncooperative patients and animals, generalanesthesia is administered with cardiovascular monitoring. To preparethe area for surgery, proper sterile precautions must be taken,including use of antiseptics like povidone-iodine and employment ofsterile drapes, gowns, and gloves. are employed. In some cases, an eyespeculum is inserted to keep the eyelids open.

A physician 7130 makes a small incision on the eye of the patient.Before the ELT procedure is performed, a small incision is made in thecornea of the eye to allow introduction of the fiber probe. Typically,the incision is about ⅛ inch or smaller.

During the excimer laser trabeculostomy procedure, a physician guidesthe delivery tip of the fiber probe through the corneal incision in theeye and towards the trabecular meshwork. The delivery tip is 7140 guidedby the physician to successive positions transverse to the Schlemm'scanal where shots are delivered (e.g., see FIG. 43 and accompanyingdescription). A Gonio lens, endoscope, and/or illumination source may beused by the physician to aid in positioning the delivery tip. Byproviding a laser probe at multiple positions for shots transverse tothe Schlemm's canal, or crosswise with respect to the Schlemm's canal,the energy from the excimer laser is delivered at multiple heights wherethe Schlemm's canal is likely to be located, thereby increasing thelikelihood of perforations through the trabecular meshwork actuallyconnecting to the Schlemm's canal. Thus, arrangement of the delivery tipat positions transverse to the Schlemm's canal achieves optimalphotoablation and formation of perforations in the meshwork and/orSchlemm's canal.

Once the delivery tip is at a given position of the successivetransverse positions, the physician 7150 applies ELT treatment to thepatient by delivering a series of shots of laser energy to thetrabecular meshwork and Schlemm's canal. The physician applies pulsedphotoablative energy. In some examples, a physician creates about 10 ELTsites in an eye of the patient. In some examples, the physician createsgreater than about 10 ELT sites per eye of the patient. A small amountof bloody reflux from Schlemm's canal confirms each opening. The fiberprobe is removed from the eye. The TOP decreases immediately afteradministering the ELT procedure.

After applying ELT treatment, a physician 7160 closes the incision.Typically, a physician uses sutures to close the incision. Somephysicians place a suture in the incision and other physicians reserve asuture for instances involving persistent leakage.

Methods of the various embodiments include 7170 analyzing post-operativeresults and 7180 reporting results and/or scheduling a post-operativefollow-up appointment with the patient after surgery. For example, thephysician's analysis may include observing a small amount of bloodyreflux from Schlemm's canal to confirm each opening. By observing thebloody reflux and drainage of aqueous humor, the physician is able toimmediately verify the effectiveness of the laser treatment. In turn,the physician may report the results to the patient, prescribepost-operative medication, such as topical antibiotics and steroiddrops, and schedule any follow-up post-operative visits with thepatient. Topical antibiotics and steroid drops are typically prescribedand used by the patient for 1 to 2 weeks post-operatively.

FIG. 43 is a perspective fragmentary view of the anatomy within theanterior chamber of an eye depicting the comeoscleral angle similar toFIG. 2 , with locations of shots applied to the trabecular meshworkdepicted with x's and shown forming a transverse line. As describedherein, an ELT procedure is performed by perforating the trabecularmeshwork 9, 13 of an eye. This permits fluid in a flow 1 to pass throughthe trabecular meshwork 9, 13 and into Schlemm's canal 11, therebyreducing the intraocular pressure in the eye. As shown, the trabecularmeshwork 9, 13 may have a height of a distance A, while the Schlemm'scanal 11, which is concealed to an ELT operator beneath the trabecularmeshwork 9, 13, may have a height of B. Because an operator may not beable to see the Schlemm's canal 11 under the trabecular meshwork 9, 13,an operator may miss the Schlemm's canal with one or more shots and anELT procedure can fail or be less effective. If an operator appliedshots in a straight line, every shot has the potential to miss theSchlemm's canal, therefore potentially causing a failed procedure.

As shown in FIG. 43 , shots 7205, 7210 may be applied in a line that istransverse to the Schlemm's canal, to ensure that at least some of theshots are correctly applied and create a perforation through thetrabecular meshwork 9, 13 and into the Schlemm's canal 11. In otherwords, since the shots 7205 and 7210 are applied in a line thattransversely crosses the width C where the trabecular meshwork 9, 13 andthe Schlemm's canal 11 actually align, some of the shots (e.g., shots7205) are successful, helping increase the likelihood that a procedureis successful.

In the example of FIG. 43 , nine total shots (x's) are shown, and atleast six of those shots are successful, with a possible seventh righton the border of being successful. As such, the method of applyingsuccessive shots along a transverse line with respect to the Schlemm'scanal may increase the number of successful outcomes by ensuring that atleast some shots are successful. Such a method may be particularlyuseful if a patient has a small Schlemm's canal, or the operatorsvisibility of a particular eye is poor. In other words, instead ofhaving to guess where Schlemm's canal is, an operator may take asystematic approach as shown in FIG. 43 to ensure that a procedure issuccessful. In various embodiments, if a certain number of successfulshots or perforations are desired, the total number of shots may beincreased. In this way, an operator can account for a certain number ofshots that may be unsuccessful. For example, nine shots are applied inFIG. 43 with at least six being successful. If it is desired to have atleast ten successful shots, the operator may apply, for example, fifteenshots or some greater number than ten, leaving room for the transverseline to have some outliers that are not successful.

Personalization of Excimer Laser Fibers

Glaucoma is a group of eye conditions which result in damage to theoptic nerve and lead to vision loss. While glaucoma can occur at anyage, it is more common in older adults and is one of the leading causesof blindness for people over the age of 60. A major risk factor inglaucoma is ocular hypertension, in which intraocular pressure is higherthan normal. An elevated intraocular pressure can lead to atrophy of theoptic nerve, subsequent visual field disturbances, and eventualblindness if left untreated.

Intraocular pressure is a function of the production of aqueous humorfluid by the ciliary processes of the eye and its drainage through atissue called the trabecular meshwork. The trabecular meshwork is anarea of tissue in the eye located around the base of the cornea and isresponsible for draining the aqueous humor into a lymphatic-like vesselin the eye called Schlemm's canal, which subsequently delivers thedrained aqueous humor into the bloodstream. Proper flow and drainage ofthe aqueous humor through the trabecular meshwork keeps the pressureinside the eye normally balanced. In open-angle glaucoma, the mostcommon type of glaucoma, degeneration or obstruction of the trabecularmeshwork can result in slowing or completely preventing the drainage ofaqueous humor, causing a buildup of fluid, which increases theintraocular pressure. Under the strain of this pressure, the optic nervefibers become damaged and may eventually die, resulting in permanentvision loss.

If treated early, it is possible to slow or stop the progression ofglaucoma. Depending on the type of glaucoma, treatment options mayinclude eye drops, oral medications, surgery, laser treatment, or acombination of any of these. For example, treatment of open-angleglaucoma may include surgical treatments, such as filtering surgery, inwhich an opening is created in the sclera of the eye and a portion ofthe trabecular meshwork is removed, and surgical implantation of stentsor implants (i.e., drainage tubes), in which a small tube shunt ispositioned within the eye to assist in fluid drainage. However, suchtreatments are highly invasive and may present many complications,including leaks, infections, hypotony (e.g., low eye pressure), andrequire post-operative, long-term monitoring to avoid latecomplications.

More recently, minimally invasive laser treatments have been used totreat glaucoma. In such treatments, the surgeon uses a laser tothermally modify and/or to puncture completely through variousstructures, including the trabecular meshwork and/or Schlemm's canal.For example, a laser trabeculostomy is a procedure in which a surgeonguides a working end of a laser fiber through a corneal incision of theeye and towards the trabecular meshwork and applies laser energy todestroy portions of the meshwork to create channels in the meshworkwhich allow aqueous humor to flow more freely into the Schlemm's canal.A great degree of precision is required during minimally invasive lasertreatments. For example, a surgeon must be able to properly position thelaser fiber at a correct position relative to the trabecular meshworkand Schlemm's canal to ensure that the resulting perforations, orchannels, created by the laser are optimal. However, current laser fiberoptions are limited. Most laser fibers are similarly constructed andhave similar features. As a result, surgeons have very few options whenselecting a laser fiber of their choice. Rather, surgeons are forced touse laser fibers that lack certain qualities that a given surgeonrequires when performing certain procedures, such as desired feel,feedback, and overall function of a laser fiber. As a result, the lasertreatment may be inadequate, as the desired drainage may not beachieved, and thus patients may require additional post-operativeprocedures to lower the intraocular pressure. For example, with currentlaser fiber options, a surgeon may position the laser too close or toofar from the trabecular meshwork and Schlemm's canal and/or position thelaser at improper angles relative to the trabecular meshwork andSchlemm's canal, resulting in unintended collateral tissue damage or thecreation of channels that inadequate and do not provide the desireddrainage.

Various embodiments provide personalized laser probes for use in lasersystems. The laser probes are single-use, disposable probes configuredfor use with a laser unit. The laser unit includes a laser source forgenerating laser energy to be provided to a laser probe coupled thereto.Each laser probe is a handheld device, which includes a handheld bodyand an optical fiber, including a fiber optic core, extendingtherethrough. Upon coupling the laser probe to the laser unit, the fiberoptic core is adapted to direct laser radiation from the laser source todelivery tip of the probe for transmitting laser energy to a desiredtreatment area. Each laser probe includes one or more characteristicstailored to a given user (e.g., a surgeon or other medical professionalto perform a procedure involving laser treatment).

The specific characteristics of any given probe are based on individualpreferences of a given user. The characteristics may generally relate toshape and/or dimensions of portions of the probe as well as physicalqualities of portions of the probe. In some embodiments, the handheldbody of a given probe may include specific dimensions, including width,length, and diameter, based on individual preferences of a surgeon toimprove fit and feel. In some embodiments, the profile of the deliverytip of the fiber optic core may be shaped based on preferences of asurgeon, wherein the tip may be beveled at a desired angle to enablemore precise control over the procedure. In some embodiments, the distalend of the laser probe may have a specific degree of flexibility orrigidity based on based on preferences of a surgeon, further providingimproved feel and maneuverability over the procedure.

The personalization of laser probes provides surgeons with tailored fit,feel, and function. Surgeons are better equipped to successfully performa given procedure that may otherwise prove difficult due to the lack ofvariation among laser fiber options. In particular, the laser probes andlaser unit of various embodiments may be used for permanent treatment ofglaucoma using laser trabeculostomy. By providing personalized laserprobes, a surgeon is more comfortable with the laser probe and able toperform the procedure with the required precision to ensure optimallaser treatment of the target area. In particular, by using apersonalized laser probe, the surgeon is able to better position laseremission transverse to the Schlemm's canal, to create perforations, orchannels, to improve fluid drainage, increase flow of aqueous humor, andreduce pressure in the eye. Arranging the laser probe at a positiontransverse to Schlemm's canal provides optimum results by providing agreater amount of surface area for photoablation by the laser, resultingin improved perforation and thus improved fluid drainage.

Various embodiments provide personalized laser probes for use in lasersystems. The laser probes are single-use, disposable probes configuredfor use with a laser unit. The laser unit includes a laser source forgenerating laser energy to be provided to a laser probe coupled thereto.Each laser probe is a handheld device, which includes a handheld bodyand an optical fiber, including a fiber optic core, extendingtherethrough. Upon coupling the laser probe to the laser unit, the fiberoptic core is adapted to direct laser radiation from the laser source todelivery tip of the probe for transmitting laser energy to a desiredtreatment area.

Each laser probe includes one or more characteristics tailored to agiven user (e.g., a surgeon or other medical professional to perform aprocedure involving laser treatment). The personalization of laserprobes provides surgeons with tailored fit, feel, and function. Surgeonsare better equipped to successfully perform a given procedure that mayotherwise prove difficult due to the lack of variation among laser fiberoptions. In particular, the laser probes and laser unit of variousembodiments may be used for permanent treatment of glaucoma using lasertrabeculostomy. By providing personalized laser probes, a surgeon ismore comfortable with the laser probe and able to perform the procedurewith the required precision to ensure optimal laser treatment of thetarget area. In particular, by using a personalized laser probe, thesurgeon is able to better position laser emission transverse to theSchlemm's canal, to create perforations, or channels, to improve fluiddrainage, increase flow of aqueous humor and reduce pressure in the eye.Arranging the laser probe at a position transverse to Schlemm's canalprovides optimum results by providing a greater amount of surface areafor photoablation by the laser, resulting in improved perforation andthus improved fluid drainage.

The system of the various embodiments may be well suited for intraocularprocedures in which laser treatment of target tissues is desired. Inparticular, the laser source and laser probes of the various embodimentsmay be used for treating glaucoma and useful in performing a lasertrabeculostomy. However, it should be noted that the system consistentwith the present disclosure can be used in any laser treatment ofvarious conditions, including other eye conditions (i.e., diabetic eyediseases, such as proliferative diabetic retinopathy or macular oedema,cases of age-related macular degeneration, retinal tears, andretinopathy of prematurity, and laser-assisted in situ keratomileusis(LASIK) to correct refractive errors, such as short-sightedness (myopia)or astigmatism) as well as other conditions in general and otherpractice areas (non-ocular practice areas).

FIG. 44 diagrams an excimer laser system, including a laser unit system8100 and a plurality of laser probes 8200(1), 8200(2), 8200(n) couplableto the laser unit system 8100. The system 8100 includes a laser source8102 for generating laser energy and a controller 8108 for controllingoutput of the laser energy. The laser source 8102 includes an excimerlaser 8104 and a gas cartridge 8106 for providing the appropriate gascombination to the laser 8104. The excimer laser 8104 is a form ofultraviolet laser that generally operates in the UV spectral region andgenerates nanosecond pulses. The excimer gain medium (i.e., the mediumcontained within the gas cartridge 8106) is generally a gas mixturecontaining a noble gas (e.g., argon, krypton, or xenon) and a reactivegas (e.g., fluorine or chlorine). Under the appropriate conditions ofelectrical stimulation and high pressure, a pseudo-molecule called anexcimer (or in the case of noble gas halides, exciplex) is created,which can only exist in an energized state and can give rise to laserlight in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 8104of the present system 8100 is an XeCl excimer laser and emits awavelength of 308 nm.

As described in greater detail herein, many of the components of thelaser unit system 8100 may be contained in a housing, such as a moveableplatform, to be provided in a setting in which the procedure is to beperformed (e.g., operating room, procedure room, outpatient officesetting, etc.) and the probes 8200(1)-8200(n) may connect to the housingfor use during treatment. Upon coupling a probe 8200 to the housing, afiber optic core of the probe 8200 is coupled to the laser source 8102and adapted to direct laser radiation from the laser source 8102,through the fiber, and to the treatment area.

The controller 8108 provides an operator (i.e., surgeon or other medicalprofessional) with control over the output of laser signals (from theexcimer laser 8104 to a fiber optic core of the probe 8200) and, inturn, control over the transmission of laser energy from probe 8200. Thecontroller 8108 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 8108 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the laser system 8100 as described herein.

FIG. 4 shows an embodiment of an excimer laser unit 100 (e.g., lasersystem 8100) provided in an instrument 400. As previously described, oneor more components of the system 100 can be contained within theinstrument 400. In the present embodiment, the laser source 8102(including the excimer laser 8104 and gas cartridge 1806) and controller8108 are contained within a housing 402. The housing 402 has wheels 404and is portable. The instrument 400 further includes a push-pull handle405 which assists with portability of the instrument 400. The instrument400 further includes a connection port 406 for receiving a connectingend of the laser probe 8200 to establish a connection between a fiberoptic core of the probe 8200 and the laser source 8102. The instrument400 further includes various inputs for the operator, such as anemergency stop button 410, and a power switch 412. The instrument 400further includes a foot pedal 414 extending from the housing 402 and isoperable to provide control over the delivery of shots from the excimerlaser 8104 to the fiber optic core of the probe 8200. The instrument 400further includes a display 416, which may be in the form of aninteractive user interface. In some examples, the interactive userinterface displays patient information, machine settings, and procedureinformation. As previously described, an operator may manually input thelaser probe data via the interactive user interface to thereby providesuch data to the controller 8108. However, in some embodiments, the datamay be automatically read from a readable device or label on the probe8200 via an associated reader of the system 8100.

As shown, the various embodiments provide for a plurality ofpersonalized laser probes 8200(1)-8200(n) for use with the excimer laserunit 8100. The laser probes 8200(1)-8200(n) are single-use, disposableprobes configured for use with a laser unit, one at a time. Uponcoupling a laser probe 8200 to the laser unit (via the connectionportion 406, the fiber optic core of the probe 8200 is adapted to directlaser radiation from the excimer laser 8104 to a delivery tip of theprobe for transmitting laser energy to a desired treatment area. As willbe described in greater detail herein, each laser probe 8200(1)-8200(n)may include one or more characteristics tailored to a given user (e.g.,a surgeon or other medical professional to perform a procedure involvinglaser treatment). As such, only single excimer laser unit 8100 isrequired and a plurality of differently configured probes8200(1)-8200(n) can be used with the unit 8100.

FIGS. 5 and 6 show an embodiment of a probe 500 that may be used withthe excimer laser system 8100 (e.g., one of the probes 8200(1)-8200(n)).FIGS. 46 and 47 show cross-sectional views of the probe 500 taken alongline A-A and line B-B of FIG. 6 , respectively. As shown, a fiber opticcore 518 runs through the probe 500 and forms part of the connector 502.A protective sheath 516 surrounds the fiber optic core 518. In someexamples, the protective sheath 516 is a protective plastic or rubbersheath. The fiber optic core 518 further form part of the delivery tip506 of the probe 500. A metal jacket 520 surrounds the fiber optic core518 and optical fiber 520. In some instances, a stainless steel jacket520 surrounds and protects the fiber optic core 518.

Each laser probe includes one or more characteristics tailored to agiven user (e.g., a surgeon or other medical professional to perform aprocedure involving laser treatment). The specific characteristics ofany given probe are based on individual preferences of a given user. Thecharacteristics may generally relate to shape and/or dimensions ofportions of the probe as well as physical qualities of portions of theprobe. In some embodiments, the handheld body 508 of a given probe mayinclude specific dimensions, including width, length, and diameter,based on individual preferences of a surgeon to improve fit and feel.

In some embodiments, the profile of the delivery tip 506 of the fiberoptic core may be shaped based on preferences of a surgeon, wherein thetip may be beveled at a desired angle to enable more precise controlover the procedure. FIG. 48 shows an enlarged view of a distal portionof a probe. FIGS. 49A and 49B show enlarged views of delivery tips 506of a probe having different bevel angles 507. For example, as shown inFIG. 49A, the bevel angle θ₁ may be greater than the bevel angle θ₁, asdetermined by a user's individual preferences. Additionally, oralternatively, the distal end of the laser probe may have a specificdegree of flexibility or rigidity based on based on preferences of asurgeon, further providing improved feel and maneuverability over theprocedure. For example, FIGS. 50 and 51 show enlarged views of a distalportion 506 a of a probe flexing in different directions (flexed distalportion 506 b). As such, the outer jacket 520 surrounding said fiberoptic core 518 may include certain materials having properties allowingfor desired flex or rigidity.

The personalization of laser probes provides surgeons with tailored fit,feel, and function. Surgeons are better equipped to successfully performa given procedure that may otherwise prove difficult due to the lack ofvariation among laser fiber options. In particular, the laser probes andlaser unit of various embodiments may be used for permanent treatment ofglaucoma using laser trabeculostomy. For example, during a lasertrabeculostomy procedure using the laser system and probes, a physicianguides the delivery tip of the probe through a corneal incision in theeye and towards the trabecular meshwork. A Gonio lens and/orillumination source may be used by the physician to aid in positioningthe delivery tip. In some examples, the physician uses a light source,such as Gonio lens, endoscope, or other illumination source, to aid inadjusting placement of the probe.

By providing personalized laser probes, a surgeon is more comfortablewith the laser probe and able to perform the procedure with the requiredprecision to ensure optimal laser treatment of the target area. Forexample, the surgeon is able to better position laser emissiontransverse to the Schlemm's canal. Once the delivery tip is at aposition transverse to the Schlemm's canal, the physician delivers aseries of shots of laser energy to the trabecular meshwork. By providinga laser probe at a position transverse to the Schlemm's canal, orcrosswise to the Schlemm's canal, the laser is delivered to a greateramount of surface area than if the laser was in a parallel orperpendicular position to the Schlemm's canal. Thus, arrangement of thedelivery tip at a position transverse to the Schlemm's canal achievesoptimal photoablation and channel formation in the meshwork and/orSchlemm's canal. The orientation and positioning of the delivery tip iscritical when creating channel formation in the tissue, as achievingtransverse placement of channels in the meshwork relative to Schlemm'scanal provides optimal drainage. Arranging the laser probe at a positiontransverse to Schlemm's canal provides optimum results by providing agreater amount of surface area for photoablation by the laser, resultingin improved perforation and thus improved fluid drainage.

Enhanced Fiber Probes for ELT

Patients suffering from glaucoma experience vision loss from a build-upof fluid in the anterior chamber of the eye. The fluid build-upincreases the pressure in the eye and causes damage to the optic nerve.If left untreated, the damage to the optic nerve will lead to blindness.

Traditional pharmaceuticals prescribed to treat glaucoma do not providea permanent solution and instead manage the condition by loweringpressure in the eye. For example, some medications decrease productionof the fluid, while other medications increase drainage of the fluid.Traditional surgical treatments are also used to lower pressure, forexample, by inserting an implant into the eye to increase drainage.However, these procedures have risks associated with them, such asdislodgement of the implant.

The various embodiments provide systems and methods of treating glaucomausing fiber probes that have a programmable number of laser shots foruse during an excimer laser trabeculostomy (ELT) procedure. ELT is aminimally invasive method of treating glaucoma that does not involveimplants. Instead, an excimer laser is used to permanently perforate thedrainage system in the eye to increase drainage of fluid. ELTinstruments require fiber probes to deliver the laser pulse to the eye.In the various embodiments, a fiber probe connected to the ELTinstrument is programmable to deliver a variable number of laser shotsand monitor the number of shots delivered by the probe, thereby allowingfor personalized treatment of glaucoma.

Existing fiber probes are operable for a fixed number of laser shots.Typically, a maximum number of laser shots is delivered by each existingfixed-use fiber probe. If a physician requires greater than 10 lasershots for treatment, the ELT procedure is interrupted in order to changeout one fixed-use fiber probe for another fixed-use fiber probe.

Because ELT procedures often require more than a standard number oflaser shots for treatment of glaucoma, the various embodiments providefiber probes programmable to increase the maximum number of laser shotsfor each probe. By programming the fiber probes, interruptions in theELT procedure are avoided, such as delays caused by replacing anexpended fixed-use fiber probe with a fresh fixed-use fiber probe inorder to continue treatment of an eye. The various embodiments thereforeavoid interruptions to the surgical process in order to allow a changeof equipment.

Methods and systems of the various embodiments allow programming of afiber probe to deliver a variable number of laser shots and monitor thenumber of shots delivered by the probe. In various embodiments, once thefiber probe is connected to the ELT instrument, the fiber probe may beprogrammed. The ELT instrument comprises an interactive user interface,or display panel, that is communicatively coupled with a controller anda processor. Settings input by the user into the interactive userinterface are processed and implemented.

In an example, a physician uses the interactive user interface to entera numerical value for the variable number of laser shots deliverable bythe probe. The numerical value for the variable number of laser shots isprogrammable within a range and is adjustable from a minimum amount to amaximum amount. For safety purposes, the manufacturer may set apredefined limit on the maximum number of shots. The physician mayprogram the variable number of deliverable laser shots up to themanufacturer-set maximum number. The ELT instrument programs thevariable number of laser shots deliverable by the fiber probe andsubsequently monitors the number of laser shots delivered by the fiberprobe. The various embodiments therefore provide personalized glaucomatreatment, which has the benefit of preventing reuse of medicalequipment and avoids the detriment of not treating a patient in anoptimal manner.

In some examples, the variable number of deliverable laser shots isdetermined based on pre-operative analysis conducted by the physician.For example, a physician may review the condition of glaucoma in thesubject and decide to administer 15 laser shots per eye using ELTtreatment. The physician is then able to program the fiber probeaccordingly and perform the ELT procedure to deliver as many laser shotsas programmed without interrupting the treatment to change out fiberprobes. Thus, various embodiments described herein provide personalizedlaser surgical intervention that increases efficiency of ELT proceduresand avoids delays from changing out fiber probes.

During the ELT procedure, after programming the fiber probe, thephysician guides the delivery tip of the fiber probe through a cornealincision in the eye and towards the trabecular meshwork. In someexamples, various embodiments further comprise administering anesthesiato the subject before making the incision and inserting the probe.Typically, the incision has a length of about ⅛ inch or smaller. In someexamples, one or more sutures are used to close the incision after ELTtreatment. The delivery tip is guided by the physician to a positiontransverse to the Schlemm's canal to create permanent perforations inthe trabecular meshwork and/or Schlemm's canal. Fluid drainage from theanterior chamber of the eye is immediately improved once perforationsare created in the meshwork and/or Schlemm's canal by the laser. Theperforations also increase blood flow and reduce pressure in the eye. Insome cases, the physician uses a Gonio lens, endoscope, or otherillumination source to aid in positioning the delivery tip of the fiberprobe.

Once the delivery tip is at a position transverse to the Schlemm'scanal, a series of shots of laser energy are delivered to the trabecularmeshwork. By providing a laser probe at a position transverse toSchlemm's canal, or crosswise to Schlemm's canal, energy from the laseris delivered to a greater amount of surface area than if the fiber probewas in a position parallel to or perpendicular to Schlemm's canal.Arrangement of the delivery tip at a position transverse to Schlemm'scanal achieves optimal photoablation and formation of perforations fordrainage.

To improve drainage of the aqueous humor from the anterior chamber ofthe eye, a plurality of permanent perforations is lasered into thetrabecular meshwork and/or Schlemm's canal by the ELT procedure. EachELT perforation has a diameter of about 200 μm, which is determined bythe dimensions of the delivery tip. These dimensions could be modifiedto increase or decrease the ELT perforation diameter. In existing fiberprobes for use in ELT procedures, the fiber probes are set to deliver amaximum, fixed number of laser shots. For example, the maximum, fixednumber may be 10 laser shots. Various embodiments allow the physician toprogram the number of laser shots deliverable by the fiber probes,thereby providing fiber probes with a variable number of deliverablelaser shots. The number of laser shots is programmable within a rangeand is adjustable from a minimum amount to a maximum amount. Accordingto various embodiments, a physician can attach a fiber probe to the ELTinstrument and enter a range for number of shots deliverable by theattached fiber probe using the interactive user interface on theinstrument. In some examples, the number of deliverable laser shots is avariable number. In some examples, the variable number of deliverableshots is greater than about 10 shots.

In an example, after examining a subject having glaucoma, a physiciandetermines that 15 shots per eye are needed for treatment. Using thevarious embodiments, the physician programs a fiber probe to deliver 15laser shots as a maximum number in the range of laser shots deliverableby the probe. In such a scenario, the physician uses a fiber probe thatis programmed to deliver 15 laser shots to treat glaucoma in a first eyeof the subject. For sterilization purposes, a second fiber is programmedand used to deliver 15 laser shots in a second eye of the subject. Thephysician uses two fiber probes during the ELT procedure, one probe foreach eye. In contrast, twice as many fiber probes would be used for thesame ELT treatment plan if the physician was using traditional, fixednumber fiber probes with 10 shots set as the maximum fixed number ofshots. A first fixed number probe would be used to apply a maximum 10shots to a first eye, the first fixed number probe would be replacedwith a second fixed number probe, and the remaining 5 shots in thetreatment plan would be applied to the first eye. The process would berepeated for treatment of a second eye of the subject, with a thirdfixed number probe used to apply a maximum 10 shots to the second eyeand a fourth fixed number probe used to apply the remaining 5 shots inthe treatment plan to the second eye.

In an embodiment, the input options on the interactive user interfaceare directed to setting the pulse, width, and amplitude of the laser.Due to safety concerns, a maximum setting for each of the pulse, width,and amplitude are typically pre-defined by the manufacturer. The usermay select values within the predefined ranges set by the manufacturer.

Various embodiments use a 308-nm xenon-chloride ultraviolet excimerlaser. The 308-nm xenon-chloride ultraviolet excimer laser causesminimal thermal damage compared with visible or infrared lasers. In someexamples, the excimer laser is an encapsulated xenon chloride (XeCl)excimer laser such as the EX TRA LASER manufactured by MLase AG. BecauseELT is a non-thermal procedure, tissue reactions in the trabecularmeshwork are not shown or activated post-operatively. The lack of heatgeneration in ELT allows for a nearly absent activation of postoperativetissue reactions and provides long-term stability of thepressure-reducing effects.

Moreover, to avoid the corneal absorption of laser radiation, an opticalfiber is used to deliver the energy. A delivery tip of the fiber probecomprises the optical fiber jacketed in metal, such as stainless steel.In some examples, the delivery tip is beveled (e.g., at 0°, 15°, 30°,and 45° with respect to the tip). The fiber probe comprises an opticalfiber suitable for UV light that is embedded into a handheld laserapplicator. In some examples, a FIDO LASER APPLICATOR manufactured byMLase AG is used as the fiber probe.

Systems and methods of the various embodiments herein treat glaucomausing excimer laser trabeculostomy (ELT). Multiple shots from theexcimer laser are administered to the patient in order to shoot holes,or perforations, in the trabecular meshwork and/or Schlemm's canal. ELTconverts trabecular meshwork tissue into gas by photoablation. Bypermanently perforating Schlemm's canal and/or the trabecular meshwork,built-up fluid in the eye is immediately allowed to drain. Moreover,because the perforations allow for increased blood flow and fluiddrainage, subsequent vision loss from damage to the optic nerve due toany build-up is thereby avoided.

In existing fiber probes for use ELT procedures, the fiber probes areset to deliver a maximum fixed number of laser shots. Variousembodiments allow the physician to program the number of laser shotsdeliverable by the fiber probes, thereby providing fiber probes thatdeliverable a variable number of laser shots. Once the delivery tip isat a position transverse to the Schlemm's canal, the physician appliespulsed photoablative energy to create ELT sites or perforations in thetrabecular meshwork and/or Schlemm's canal. In some examples, aphysician creates greater than about 10 ELT sites per eye.

FIG. 52 shows a flowchart of an embodiment 9100. Various embodiments aredirected to treating a patient having glaucoma with ELT. In variousembodiments, the energy shots delivered from the excimer laser are at aposition transverse to the Schlemm's canal. In some examples, methodsinclude 9110 pre-operative analysis, such as diagnosis of the eyecondition, inspection and/or visualization of the anterior chamber ofthe eye to aid in placement of the laser probe, and analysis of numberof laser shots needed for treatment. In various embodiments, excimerlaser trabeculostomy (ELT) is used to treat glaucoma.

Methods of the various embodiments include 9120 programming the numberof shots deliverable by the fiber probe. In existing fiber probes foruse ELT procedures, the fiber probes are set to deliver a maximum, fixednumber of laser shots. Methods and systems of the various embodimentsallow the physician to program the number of laser shots deliverable bythe fiber probes. The number of laser shots is programmable within arange and is adjustable from a minimum amount to a maximum amount. Aphysician can attach a fiber probe to the ELT instrument and use theinteractive user interface on the instrument, and subsequently thecontroller and processor of the ELT system, to program the fiber probeto deliver a range of laser shots.

Some embodiments of the method include 9130 administering anesthesia tothe patient. Topical anesthesia is commonly employed, typically by theinstillation of a local anesthetic such as tetracaine or lidocaine.Lidocaine and/or a longer-acting bupivacaine anesthetic may be injectedinto the area surrounding (peribulbar block) or behind (retrobulbarblock) the eye muscle cone to more fully immobilize the extraocularmuscles and minimize pain sensation. Optionally, a facial nerve blockmay be performed using lidocaine and bupivacaine to reduce lidsqueezing. In some cases, such as for children, patients with traumaticeye injuries, and nervous or uncooperative patients and animals, generalanesthesia is administered with cardiovascular monitoring. To preparethe area for surgery, proper sterile precautions must be taken,including use of antiseptics like povidone-iodine and employment ofsterile drapes, gowns, and gloves. In some cases, an eye speculum isinserted to keep the eyelids open.

Methods of the various embodiments further include a physician 9140making a small incision on the eye of the patient. Before the ELTprocedure is performed, a small incision is made in the cornea of theeye to allow introduction of the laser probe. Typically, the incision isabout ⅛ inch or smaller. During the ELT procedure, a physician guides adelivery tip of a fiber probe through the corneal incision in the eyeand towards the trabecular meshwork. The delivery tip is guided by thephysician to a position transverse to the Schlemm's canal. A Gonio lens,endoscope, and/or illumination source may be used by the physician toaid in positioning the delivery tip. By providing a laser probe at aposition transverse to the Schlemm's canal, or crosswise to theSchlemm's canal, the laser is delivered to a greater amount of surfacearea than if the laser was in a parallel or perpendicular position tothe Schlemm's canal. Thus, arrangement of the delivery tip at a positiontransverse to the Schlemm's canal achieves optimal photoablation andformation of perforations in the meshwork and/or Schlemm's canal. Theorientation and positioning of the delivery tip is critical whencreating perforations in the tissue, as achieving transverse placementof perforations in the meshwork relative to Schlemm's canal providesoptimal drainage.

Once the delivery tip is at a position transverse to the Schlemm'scanal, the physician 9150 applies ELT treatment to the patient bydelivering a series of shots of laser energy to the trabecular meshworkand Schlemm's canal. The physician applies pulsed photoablative energyto create ELT sites or perforations in the trabecular meshwork and/orSchlemm's canal. Unlike traditional fiber probes that have a maximum,fixed number of deliverable laser shots, methods of the variousembodiments allow the physician to program the number of shotsdeliverable by the fiber probe. The number of laser shots deliverable byfiber probes according to methods and systems of the various embodimentsis programmable within a range and is adjustable from a minimum amountto a maximum amount.

In some examples, a physician uses a programmed fiber probe to creategreater than about 10 ELT sites in an eye of the patient. A small amountof bloody reflux from Schlemm's canal confirms each opening. The fiberprobe is removed from the eye. Notably, the TOP decreases immediatelyafter administering the ELT procedure.

After applying ELT treatment, a physician 9160 closes the incision.Typically, a physician uses sutures to close the incision. Somephysicians place a suture in the incision and other physicians reserve asuture for when there is persistent leakage.

Methods of the various embodiments include 9170 analyzing post-operativeresults and 9180 reporting results and/or scheduling a post-operativefollow-up appointment with the patient after surgery. For example, thephysician's analysis may include observing a small amount of bloodyreflux from Schlemm's canal to confirm each opening. By observing thebloody reflux and drainage of aqueous humor, the physician is able toimmediately verify the effectiveness of the laser treatment. In turn,the physician may report the results to the patient, prescribepost-operative medication, such as topical antibiotics and steroiddrops, and schedule a follow-up post-operative visit with the patient.For example, topical antibiotics and steroid drops are used by thepatient for 1 to 2 weeks post-operatively.

FIG. 53 shows a stylized embodiment of an interactive user interface9410 (e.g., 416 of FIGS. 4, 21, 32, 45 ; 6310 of FIG. 41 ; etc.)according to various embodiments. The interactive user interface 9410 isan interactive display screen on the ELT instrument. The interactiveuser interface 9410 is communicatively coupled with the controller,which allows the user (e.g., physician) to view and change settingsusing the interactive user interface 9410, such as via haptic feedbackand/or touchscreen technologies. The interactive user interface displaysa variety of information and settings, such as patient information,instrument information, and instrument settings.

Different information is displayed on a plurality of interchangeabledisplay screens. For example, one screen may display setting informationfor the fiber probe, such as shown in FIG. 53 , while another screendisplays patient information. The user can view different screens byusing button 9425 to return to a previous screen or using button 9427 tomove forward to a next screen. In the embodiment shown in FIG. 53 , asettings screen 9411 is shown for the fiber probe. Display box 9413designates the setting, which is the maximum number of laser shots forthe fiber probe. Display box 9415 shows the maximum number of lasershots that the user has input. To change the set maximum number of lasershots, the user can select button 9417 to increase the number in box9415 and button 9419 to decrease the number in box 9415. Display box9421 indicates the number of laser shots that have been fired from theprobe, with the changing number shown in box 9423. The embodiment shownin FIG. 53 indicates that the fiber probe has been programmed to deliver12 shots as the maximum number of laser shots, and so far, the fiberprobe has delivered 8 laser shots.

In an embodiment, the input options on the display screen are directedto setting the pulse, width, and amplitude of the laser. Due to safetyconcerns, a maximum setting for each of the pulse, width, and amplitudemay be pre-defined by the manufacturer. The user may select valueswithin the predefined ranges set by the manufacturer.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

Various modifications of the various embodiments described herein andmany further embodiments thereof, in addition to those shown anddescribed herein, will become apparent to those skilled in the art fromthe full contents of this document, including references to thescientific and patent literature cited herein. The subject matter hereincontains important information, exemplification and guidance that can beadapted to the practice of the various embodiments and equivalentsthereof.

What is claimed is:
 1. A method of delivering laser energy to a surfaceof a trabecular meshwork of an eye comprising: inserting a probe into aneye of a subject having glaucoma; adjusting placement of the probe to afirst position proximate to the trabecular meshwork in the eye;delivering a first shot from a laser source to create a firstperforation in the trabecular meshwork; adjusting placement of the probeto a second position proximate to the trabecular meshwork; anddelivering a second shot from the laser source to create a secondperforation in the trabecular meshwork, wherein the first perforationand the second perforation form a line that runs transverse to aSchlemm's canal of the eye, and wherein at least one of the firstperforation or the second perforation is successful in perforating thetrabecular meshwork between the Schlemm's canal and an anterior chamberof the eye, causing bloody reflux to exit the at least one of the firstperforation or the second perforation into the anterior chamber.
 2. Themethod of claim 1, further comprising adjusting placement of the probeto subsequent positions proximate to the trabecular meshwork anddelivering subsequent shots from the laser source to create subsequentperforations in the trabecular meshwork, wherein the first perforation,the second perforation, and the subsequent perforations form a line orcurve that runs transverse to the Schlemm's canal of the eye.
 3. Themethod of claim 1, wherein the laser source comprises an excimer lasersource.
 4. The method of claim 1, wherein one of the first perforationin the trabecular meshwork or the second perforation in the trabecularmeshwork is formed outside of a boundary of the Schlemm's canal.
 5. Themethod of claim 1, wherein the probe is inserted into an incision in theeye.
 6. The method of claim 1, wherein a light source comprising a Goniolens, endoscope, or other illumination source aids in adjustingplacement of the probe.
 7. The method of claim 1, wherein each of thefirst perforation in the trabecular meshwork and the second perforationin the trabecular meshwork has a diameter of 200 μm.
 8. The method ofclaim 1, further comprising analyzing effectiveness of the first shotand the second shot by visualizing drainage of aqueous humor and bloodyreflux.
 9. The method of claim 1, wherein the probe is an optical fiberprobe.
 10. An apparatus for delivering laser energy to a surface of atrabecular meshwork of an eye to treat glaucoma comprising: an excimerlaser source; a probe configured to connect to the excimer laser source;and a delivery tip connected to the probe, wherein the probe isconfigured to: be inserted into the eye of a subject having theglaucoma; be moved to a first position proximate to the trabecularmeshwork in the eye; deliver a first shot from the excimer laser sourceto create a first perforation in the trabecular meshwork; be moved to asecond position proximate to the trabecular meshwork; and deliver asecond shot from the excimer laser source to create a second perforationin the trabecular meshwork, wherein the first perforation and the secondperforation form a line that runs transverse to a Schlemm's canal of theeye.
 11. The apparatus of claim 10, wherein at least one of the firstperforation in the trabecular meshwork or the second perforation in thetrabecular meshwork is formed outside of a boundary of the Schlemm'scanal.
 12. The apparatus of claim 10, wherein at least one of the firstperforation in the trabecular meshwork or the second perforation in thetrabecular meshwork does not create a fluid connection between theSchlemm's canal and an anterior chamber of the eye located between acornea of the eye and a lens of the eye.
 13. The apparatus of claim 10,wherein at least one of the first perforation in the trabecular meshworkor the second perforation in the trabecular meshwork is aligned with theSchlemm's canal.
 14. The apparatus of claim 10, wherein at least one ofthe first perforation in the trabecular meshwork or the secondperforation in the trabecular meshwork creates a fluid connectionbetween the Schlemm's canal and an anterior chamber of the eye locatedbetween a cornea of the eye and a lens of the eye.
 15. The apparatus ofclaim 10 further comprising a light source, wherein the light sourcecomprises a Gonio lens, endoscope, or other illumination sourceconfigured to aid in placement of the probe.
 16. The apparatus of claim10, wherein each of the first perforation in the trabecular meshwork andthe second perforation in the trabecular meshwork has a diameter of 200μm.
 17. The apparatus of claim 10, wherein the probe is configured to beinserted into an incision in the eye of the subject having the glaucoma.18. The apparatus of claim 10, wherein the probe is an optical fiberprobe.
 19. The apparatus of claim 10, wherein the excimer laser sourcecomprises a xenon chloride laser.
 20. The apparatus of claim 10, whereinthe probe is configured to physically contact the trabecular meshworkwhile delivering the first shot and the second shot, wherein the firstperforation in the trabecular meshwork and the second perforation in thetrabecular meshwork are created while the probe is physically contactingthe trabecular meshwork.